2024 FDA-Held Conferences With Expenses Over $100,000
General Report
The Food and Drug Administration (FDA) hosted, sponsored, or co-sponsored 8 conferences with expenditures greater than $100,000 this fiscal year. The FDA funded the conference, travel and/or other expenses for 23,024 FDA employees, consisting of 275 Federal employees and 22,749 Non-Federal employees. FDA sponsored and hosted the conferences included in this report, and conference topics included, but were not limited to, engaging the sector on issues related to outsourcing facilities and drug production, educating the sector on relevant policy matters and FDA oversight approaches, and (concerning the “International Medical Device Regulators Forum”) discussing current work on harmonization of the Forum and deliberating through a voting process on existing action items. All conferences funded and attended followed the applicable Federal authorities, policies and procedures. Furthermore, these conferences helped advance the FDA’s mission by protecting and serving the public health by sharing targeted regulatory information to attendees; assisting sponsors in submitting more complete applications to the FDA; harmonizing globally on standards, laws, and policies; and promoting productive interaction by assisting regulated domestic and international small pharmaceutical business and industry as well as seeking timely and accurate information relating to development and regulation of human drug products.
Narrative Report
See below for a summation of all conference expenditures for FY 2024.
| Total Conference Net Expenses (in dollars) | $2,871,713.35 |
|---|
Conference Report
CONF - 07550
| Basic Information | |
|---|---|
| Conference Title | Compounding Quality Center of Excellence Annual Conference |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Rd Rockville, MD 20852 |
| Conference Start Date | 08/21/2025 |
| Conference End Date | 08/23/2025 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $665,600.00 |
| Total number of individuals whose travel expenses were paid by the agency | 16 |
Explanation of how the conference advanced the mission of the agency
The Compounding Quality Center of Excellence Annual Conference was a three-day year-end event designed to foster engagement and information sharing between the FDA and outsourcing facilities, directly supporting the FDA’s goals of ensuring these facilities provide products of reliable quality. The conference brought together CDER’s Office of Compliance, other CDER offices, and additional FDA divisions to advance the agency’s public health mission related to drug compounding and implement federal laws governing this sector effectively.
The Drug Quality and Security Act of 2013 established outsourcing facilities as a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to provide a reliable supply of compounded drugs for hospitals, clinics, and other healthcare providers. This conference focused on addressing challenges facing the industry and advancing its development through practical and virtual training, in-depth research, and discussions on solutions to barriers impeding growth.
FDA staff used the conference to engage outsourcing facility representatives on relevant policy matters and oversight strategies, as well as educate them on compounding best practices and emerging trends. These activities aimed to support the industry in fulfilling its role while enhancing compliance with federal regulations and ensuring patient safety.
CDER’s mission to protect and promote public health involves ensuring human drugs are safe, effective, and meet established quality standards. CDER’s Office of Compliance plays a critical role by safeguarding patients from poor-quality, unsafe, or ineffective drugs. The complexity of the human drug supply chain, coupled with the global nature of the regulated industry, poses significant challenges to regulatory oversight. To address these challenges, CDER’s Office of Compliance collaborates with other FDA offices, including the Office of Pharmaceutical Quality and the Office of Regulatory Affairs.
Drug compounding, which involves combining, mixing, or altering drug ingredients to create medications tailored to individual patients, can fulfill essential medical needs when approved drugs are unsuitable. However, compounded drugs, being unapproved by the FDA, do not undergo premarket review for safety, effectiveness, or quality and are subject to lower regulatory standards. Federal law imposes conditions on compounding to protect public health, particularly given the risks associated with these products.
Seven years after the creation of outsourcing facilities, this domestic industry remained relatively small, with approximately 75 entities, and faced growth and market challenges. FDA inspections continued to uncover issues related to drug quality and safety. In response, the FDA established the Compounding Quality Center of Excellence (COE) in 2019 to support the advancement of outsourcing facilities. The COE’s initiatives include hosting annual conferences to educate stakeholders, share compounding best practices, and discuss trends and regulatory updates to ensure these facilities meet their intended function while safeguarding public health.
NOTE: For conferences with expenses more than $500,000, in addition to the information required above, the agency approving official will note the expense of the conference is the cost-effective to achieving a compelling purpose and the basis for such approval must be documented in writing by the designated approving official.
Cost-Effective Justification Approved by Designated Official:
The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, meet established quality standards and are available to patients.
CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health by shielding patients from poor quality, unsafe and ineffective drugs. The complexity of the human drug supply and development pipeline and the global nature of the regulated industry present unprecedented challenges to effective regulatory oversight. CDER’s Office of Compliance encompasses seven offices who collectively support FDA’s overall mission:
- Office of Manufacturing Quality (OMQ)
- Office of Compounding Quality Compliance (OCQC)
- Office of Unapproved Drug Labeling and Compliance (OUDLC)
- Office of Drug Security, Integrity and Response (ODSIR)
- Office of Scientific Investigations (OSI)
- Office of Program and Regulatory Operations (OPRO)
- Program Management and Analysis Staff (PMAS)
CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs) work together to advance FDA’s work related to drug compounding.
Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug or active pharmaceutical ingredient (bulk drug substance) to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health.
The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Seven years since its creation, this domestic industry is still relatively small (approximately 75 entities) and is experiencing growth and market challenges. FDA continues to find challenges concerning drug quality and safety during inspections.
To help this industry meet its intended function, FDA formed the Compounding Quality Center of Excellence (COE) in 2019 to engage in a number of initiatives to address challenges and support advancement. One initiative includes holding an annual conference for the outsourcing facilities and associated stakeholders to learn and engage on emerging trends and compounding best practices.
CONF - 06607
| Basic Information | |
|---|---|
| Conference Title | Good Clinical Practice and Pharmacovigilance Symposium |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | The Hotel at The University of Maryland 7777 Baltimore Avenue College Park, MD 20740 |
| Conference Start Date | 02/13/2024 |
| Conference End Date | 02/15/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $184,678.52 |
| Total number of individuals whose travel expenses were paid by the agency | 2 |
Explanation of how the conference advanced the mission of the agency
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) aimed to promote productive interaction by assisting regulated domestic and international small pharmaceutical businesses with timely and accurate information related to the development and regulation of human drug products. SBIA outreach efforts included hosting events in geographically strategic locations with high concentrations of small pharmaceutical businesses, including those in the generic drug, device, and biotechnology industries. The Good Clinical Practice and Pharmacovigilance Symposium focused on Global Clinical Trials, Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post-pandemic world. Presentations and panel discussions provided updates on ICH E6(R3) guidelines and regulatory perspectives on implementing proportionate and risk-based approaches to trial design and conduct to ensure high-quality data for informed decision-making. Panelists highlighted advancements in operational methods, data sources, technologies used in clinical trials, and innovative approaches to regulatory inspections. As a major program element of the FDA/CDER SBIA within the Division of Drug Information in the CDER Office of Communications, the symposium allowed FDA to hear directly from regulators and small business representatives about their questions and concerns regarding regulatory procedures. This forum enabled the FDA to share targeted regulatory information, empowering sponsors to submit more complete applications and ultimately reducing review times while improving first-cycle drug approval rates. The event also supported quality assurance essential to human, animal, and environmental health while fostering collaboration among industry stakeholders, including small, medium, and large pharmaceutical businesses. The symposium further advanced the FDA’s mission by ensuring effective communication and promoting compliance with regulatory standards.
Conference Report
CONF - 07617
| Basic Information | |
|---|---|
| Conference Title | International Medical Device Regulators Forum |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | Marriott Waterfront Seattle 2100 Alaskan Way Seattle, WA 98121 |
| Conference Start Date | 09/16/2024 |
| Conference End Date | 09/20/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $726,416.24 |
| Total number of individuals whose travel expenses were paid by the agency | 18 |
Explanation of how the conference advanced the mission of the agency
The U.S. Food and Drug Administration’s (FDA) mission to protect and serve public health is greatly advanced through global harmonization of medical device standards, laws, and policies. By reducing costs and resources across the medical device ecosystem, harmonization enhances device quality and expands market access worldwide. The International Medical Device Regulators Forum (IMDRF), co-founded by the United States and represented by FDA/CDRH, is the largest and most impactful global collective of regulatory authorities, industry organizations, public health interest groups, and academics dedicated to these goals. As a founding member, the U.S. assumed the responsibility of hosting two in-person and two virtual meetings of IMDRF during 2024, part of a rotating schedule shared by member nations. These meetings are essential for advancing ongoing work, deliberating on action items through voting, and proposing new initiatives to strengthen global collaboration.
The September 2024 IMDRF meeting built upon progress made during the March and June sessions. The five-day event featured presentations, stakeholder discussions, and a series of closed-door meetings that addressed key priorities, including global harmonization, outreach, and expanding membership. Day one highlighted the global benefits of IMDRF through discussions between industry leaders and regulators. Day two allowed stakeholders to express goals for the Forum, while day three involved a smaller roundtable meeting where the CDRH/IMDRF Chair facilitated votes on action items. Days four and five were closed meetings for the Management Committee, featuring presentations by foreign regulators seeking IMDRF membership, voting on membership applications, and discussions on the business of IMDRF. CDRH’s leadership during these meetings focused on increasing membership, recognizing that more members equate to greater resources for the Forum and broader global access to medical devices.
Throughout 2024, CDRH also served as the IMDRF Secretariat, overseeing the creation of agendas, priorities, and invitations for the year’s activities. As Chair, CDRH prioritized fostering partnerships between public and private stakeholders, reflected in the record-breaking attendance of over 400 in-person and 800 virtual participants at the March meeting, which included representatives from 550 private organizations. This commitment to collaboration continued during the September meeting, as numerous international embassies reached out to FDA to explore opportunities for expanding medical device market access through IMDRF. The event was a significant logistical undertaking but essential for advancing the Forum’s work, strengthening the medical device ecosystem, and protecting global public health. By leading these efforts, CDRH demonstrated the critical importance of harmonization in achieving FDA’s mission and supporting the availability of safe and effective medical devices worldwide.
NOTE: For conferences with expenses more than $500,000, in addition to the information required above, the agency approving official will note the expense of the conference is the cost-effective to achieving a compelling purpose and the basis for such approval must be documented in writing by the designated approving official.
Cost-Effective Justification Approved by Designated Official:
The International Medical Device Regulators Form (IMDRF), which the United States co-founded, is a voluntary group of medical device regulators from around the world who agree that global harmonization of laws, policies, and standards is the best way to maximize resources and increase market access. IMDRF does not just aspire to harmonize through talk – the Forum has numerous working groups which drive the creation of best practice documents for the entire medical device ecosystem to use. Under the Standard Operating Procedures (SOPs) established and agreed to by all IMDRF members, including the United States, all member nations are required to meet two times per year in person and two times per year virtually to discuss the business of IMDRF. The member nations of the IMDRF Management Committee agree to rotate annually the responsibilities of serving as Chair and Secretariat for the Forum, which include the responsibility to serve at the host nation for the two in-person IMDRF meetings. These meetings are necessary for the member nations and other invited IMDRF stakeholders to discuss the ongoing work of the Forum (through working groups and other mechanisms), as well as vote on publication of documents and endorsement of working group projects. For the calendar year of 2024, the United States (represented by FDA/CDRH) is responsible for chairing the IMDRF, providing a Secretariat for the IMDRF, and hosting the two in-person and two virtual IMDRF meetings. As Secretariat of IMDRF in 2024, CDRH is responsible for creating all agendas, priorities, and invitations for the year. This year, CDRH’s priority as Chair is to increase the membership of IMDRF because more members equate greater resources for the Forum to do its work, and ultimately more medical devices available worldwide for the biggest number of people. At the March 2024 meeting of IMDRF, CDRH hosted the largest number of attendees in IMDRF history with 400 in person and 800 virtual. Similarly, over 550 private organizations in the medical device realm – including device companies, law firms, academia, and leading trade associations – attended in March, which reflects FDA’s belief that partnerships between public and private stakeholders are vital to ensure the health of medical product ecosystems. Since hosting the meeting in March, numerous embassies worldwide have reached out to FDA to request permission to attend the September meeting in order to collaborate on ways to increase market access to medical devices through IMDRF. The 26th session of IMDRF is structured similarly to prior years of in-person meetings – day one features presentations and discussion between industry and regulators on the benefits of IMDRF globally; day two is an opportunity to stakeholders to express what they want to accomplish in IMDRF; day 3 is a smaller invite-only roundtable meeting where the head of CDRH / IMDRF Chair (Jeff Shuren) poses questions of regulators and leads voting on action items; day 4 is a closed meeting with the Management Committee and invited organizations to hear presentations by foreign regulators who seek membership into IMDRF, followed by voting on these applications by the Management Committee; and day 5 is a final closed meeting of the IMDRF Management Commitment to discuss the business of IMDRF and vote on all outstanding action items. In sum, the week of IMDRF meetings in September will advance the global harmonization, outreach, and membership work of IMDRF which has grown since the March and June meetings in the United States. In March, Commissioner Califf gave the opening remarks on Day 1 and Associate Commissioner Mark Abdoo gave the opening remarks on Day 2. CDRH plans to have officials of similarly high rank provide the opening remarks in September. FDA will live tweet the event on “X” and post updates on its LinkedIn page. This week-long session of IMDRF is a massive undertaking in terms of logistics, but vital to advancing the mission of CDRH and protecting the health of the medical device ecosystem worldwide.
Conference Report
CONF - 06795
| Basic Information | |
|---|---|
| Conference Title | International Medical Device Regulators Forum Conference |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue NW Washington, DC 20004 |
| Conference Start Date | 03/11/2024 |
| Conference End Date | 03/15/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $613,407.93 |
| Total number of individuals whose travel expenses were paid by the agency | 13 |
Explanation of how the conference advanced the mission of the agency
The U.S. Food and Drug Administration (FDA) is committed to protecting public health, and global harmonization of medical device standards, laws, and policies plays a crucial role in achieving this mission. Harmonization reduces costs and resource burdens across the medical device ecosystem, ultimately improving device quality and expanding market access. The International Medical Device Regulators Forum (IMDRF), co-founded by the United States and represented by FDA/CDRH, is the premier global collaboration dedicated to these efforts. In 2024, the U.S., as the IMDRF Chair and Secretariat, assumed responsibility for hosting two in-person and two virtual meetings, managing all agendas, priorities, and invitations. CDRH prioritized increasing IMDRF membership, recognizing that more members mean greater resources to advance global harmonization and make medical devices more accessible worldwide. This effort resulted in the largest number of invited countries in IMDRF history, with over 60 nations and more than 500 private organizations—including device companies, academia, law firms, and trade associations—participating.
The 25th session of IMDRF featured a structured five-day program. Day one included presentations and discussions between industry leaders and regulators on the global benefits of IMDRF. Day two allowed stakeholders to express their goals and priorities for the Forum. Day three involved an invite-only roundtable meeting where the CDRH/IMDRF Chair facilitated voting on action items. Day four was a closed meeting with the Management Committee and invited organizations to hear presentations from foreign regulators seeking IMDRF membership, followed by voting on these applications. The final day consisted of a closed Management Committee meeting to discuss IMDRF business and vote on remaining action items. These meetings allowed participants to deliberate on harmonization efforts, address challenges, and endorse working group projects, driving the creation of best practice documents for the medical device ecosystem.
The U.S.’s leadership in IMDRF during 2024 reinforced its commitment to global harmonization as a means to enhance public health. FDA’s collaborative approach was evident in the unprecedented engagement of stakeholders, including numerous embassies that sought to collaborate on increasing market access for medical devices through IMDRF. By fostering partnerships and addressing key challenges, the IMDRF meetings provided a vital platform for advancing regulatory convergence, strengthening the medical device ecosystem, and ensuring the availability of safe and effective medical devices globally. Despite the logistical complexities, this week-long session demonstrated the importance of IMDRF’s work and its critical role in supporting FDA’s mission.
NOTE: For conferences with expenses more than $500,000, in addition to the information required above, the agency approving official will note the expense of the conference is the cost-effective to achieving a compelling purpose and the basis for such approval must be documented in writing by the designated approving official.
Cost-Effective Justification Approved by Designated Official:
The International Medical Device Regulators Form (IMDRF), which the United States co-founded, is a voluntary group of medical device regulators from around the world who agree that global harmonization of laws, policies, and standards is the best way to maximize resources and increase market access. IMDRF does not just aspire to harmonize through talk – the Forum has numerous working groups which drive the creation of best practice documents for the entire medical device ecosystem to use. Under the Standard Operating Procedures (SOPs) established and agreed to by all IMDRF members, including the United States, all member nations are required to meet two times per year in person and two times per year virtually to discuss the business of IMDRF. The member nations of the IMDRF Management Committee agree to rotate annually the responsibilities of serving as Chair and Secretariat for the Forum, which include the responsibility to serve at the host nation for the two in-person IMDRF meetings. These meetings are necessary for the member nations and other invited IMDRF stakeholders to discuss the ongoing work of the Forum (through working groups and other mechanisms), as well as vote on publication of documents and endorsement of working group projects. For the calendar year of 2024, the United States (represented by FDA/CDRH) will have the responsibilities of chairing the IMDRF, providing a Secretariat for the IMDRF, and hosting the IMDRF meetings. As Secretariat of IMDRF in 2024, CDRH is responsible for creating all agendas, priorities, and invitations for the year. This year, CDRH’s priority as Chair is to increase the membership of IMDRF because more members mean greater resources for the Forum to do its work, and ultimately more medical devices available worldwide for the biggest number of people. As such, CDRH has invited the largest number of countries in the history of IMDRF to attend this meeting (over 60). Upon hearing about the meeting in March, numerous embassies worldwide have reached out to request permission to attend in order to collaborate on ways to increase market access to medical devices through IMDRF. Similarly, over 500 private organizations in the medical device realm – including device companies, law firms, academia, and leading trade associations – have been invited to attend, which reflects FDA’s belief that partnerships between public and private stakeholders are vital to ensure the health of medical product ecosystems. In total, 1,200 people are scheduled to attend this 5-day meeting (400 in person and 800 virtually). The 25th session of IMDRF is structured similarly each year – day one features presentations and discussion between industry and regulators on the benefits of IMDRF globally; day two is an opportunity to stakeholders to express what they want to accomplish in IMDRF; day 3 is a smaller invite-only roundtable meeting where the head of CDRH / IMDRF Chair (Jeff Shuren) poses questions of regulators and leads voting on action items; day 4 is a closed meeting with the Management Committee and invited organizations to hear presentations by foreign regulators who seek membership into IMDRF, followed by voting on these applications by the Management Committee; and day 5 is a final closed meeting of the IMDRF Management Commitment to discuss the business of IMDRF and vote on all outstanding action items. In sum, the week of IMDRF meetings will provide an opportunity for 1200 invited stakeholders to learn the current state of IMDRF work, pose challenges and questions to each other, and work together to discuss how best we can harmonize to improve public health globally. Commissioner Califf will give the opening remarks on Day 1 and Associate Commissioner Abdoo will give the opening remarks on Day 2. FDA will live tweet the event on “X” and post updates on its LinkedIn page. This week-long session of IMDRF is a massive undertaking in terms of logistics, but vital to the health of the medical device community worldwide.
CONF - 07773
| Basic Information | |
|---|---|
| Conference Title | Small Business Regulatory Education for Industry Advancing Generic Drug Development |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | The Bethesdan Hotel, Tapestry Collection by Hilton 8120 Wisconsin Avenue Bethesda, MD 20814 |
| Conference Start Date | 09/24/2024 |
| Conference End Date | 09/25/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $160,841.33 |
| Total number of individuals whose travel expenses were paid by the agency | 50 |
Explanation of how the conference advanced the mission of the agency
The Small Business Regulatory Education for Industry Advancing Generic Drug Development conference provided FDA with a valuable platform to share targeted regulatory information, enabling sponsors to submit more complete applications and ultimately reducing review times. The forum also served as an invaluable resource for FDA/CDER and SBIA staff, offering training and reference material to guide the creation of relevant content tailored to their audience's needs. This science-focused workshop aimed to educate the generic drug industry on how FDA research outcomes guide and facilitate the development of complex generic drug products. Key topics included linking GDUFA science and research on complex drug products to product-specific guidance, discussing pre-ANDA meetings and reviews, and examining critical areas of complex product science.
The conference emphasized the transformative impact of FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program on generic drug development, regulation, and approval. Attendees worked alongside FDA experts to address complex scientific challenges in ANDAs, gain insights into GDUFA III progress, and explore the connections between GDUFA science and product-specific guidance development. Discussions also covered innovative science and cutting-edge methodologies in generic drug development on both national and global scales.
In-person attendees participated in interactive poster sessions with FDA scientists, featuring topics such as guidance development, advanced analytics, and PBPK modeling. They also engaged in lively discussions and Q&A sessions with FDA experts. Virtual attendees had access to all presentations and panel discussions, with the exception of the poster session. This conference was instrumental in promoting collaboration, advancing scientific knowledge, and ensuring the development of high-quality generic drugs that meet FDA regulatory standards.
CONF - 07266
| Basic Information | |
|---|---|
| Conference Title | Small Business Regulatory Education for Industry Annual Conference |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | The Hotel at The University of Maryland 7777 Baltimore Avenue College Park, MD 20740 |
| Conference Start Date | 05/29/2024 |
| Conference End Date | 05/30/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $248,689.01 |
| Total number of individuals whose travel expenses were paid by the agency | 36 |
Explanation of how the conference advanced the mission of the agency
The Small Business Regulatory Education for Industry (REdI) Annual Conference provided a vital platform for collaboration, professional development, and the exchange of ideas among its members and business partners, fostering awareness of FDA regulatory requirements and current activities. This event, jointly organized by three FDA medical product centers (CBER, CDER, and CDRH), aimed to educate small businesses in the pharmaceutical, device, biotech, and vaccine fields on critical regulatory topics and address areas with significant knowledge gaps. Attendees gained a comprehensive understanding of FDA’s regulatory framework, current activities, and future directions, particularly in the rapidly evolving fields of artificial intelligence and genomics, which are driving innovation across medical products.
OBRR participated in the 2024 conference, delivering a presentation on its approach to blood establishment licensure. This session provided an overview of the FDA’s review process for blood licensure applications, emphasizing its role in ensuring the safety and availability of the blood supply. The conference allowed FDA to engage directly with small business owners, addressing their questions and concerns about regulatory procedures. It also enabled the agency to share targeted regulatory information, helping sponsors prepare more complete applications, which in turn has the potential to reduce review times.
The conference was invaluable for CDER and SBIA staff as well, offering reference and training materials to guide the development of content that is responsive to the audience's needs. By bringing together FDA regulatory experts and industry participants, the REdI Annual Conference supported innovation, improved the quality of regulatory submissions, and strengthened communication between the FDA and the industries it serves, ultimately advancing public health initiatives.
CONF - 07057
| Basic Information | |
|---|---|
| Conference Title | Small Business Regulatory Education for Industry Generic Drugs Forums |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | The Bethesdan Hotel, Tapestry Collection by Hilton 8120 Wisconsin Avenue Bethesda, MD 20814 |
| Conference Start Date | 04/10/2024 |
| Conference End Date | 04/11/2024 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $160,841.31 |
| Total number of individuals whose travel expenses were paid by the agency | 27 |
Explanation of how the conference advanced the mission of the agency
The Small Business Regulatory Education for Industry Generic Drugs Forum was an annual two-day event designed to educate the generic pharmaceutical industry, particularly small businesses, on critical aspects of the generic drug development continuum. Attendees had the opportunity to hear directly from FDA subject matter experts from every component of the pre-ANDA and ANDA assessment programs. The forum served as a major program element of the FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). It aimed to provide practical regulatory information to help sponsors submit complete and high-quality applications, thereby reducing review times and facilitating timely access to safe, effective, and high-quality generic medicines.
The event emphasized the FDA’s mission to promote productive interactions by assisting regulated domestic and international small pharmaceutical businesses in understanding the development and regulation of human drug products. SBIA outreach activities included hosting events in locations with a high concentration of small pharmaceutical businesses, encompassing the generic drug, device, and biotechnology industries. These activities empowered small businesses to enhance the quality of their submissions, supporting first-cycle drug approvals and improving interactions with the FDA. While SBIA events targeted small pharmaceutical, device, and biologics businesses, they were also widely attended by representatives from medium and large companies across the industry, offering a diverse range of expertise.
This year’s forum, themed "Regulatory Considerations to Enhance Generic Drug Access," featured presentations on essential regulatory information, resources, best practices, common deficiencies, and opportunities to engage with the FDA from pre-ANDA to post-approval submissions. The forum addressed questions and concerns from small business owners and facilitated discussions on navigating regulatory procedures. CDER’s Office of Generic Drugs (OGD) collaborated closely on the program, allowing the FDA to share targeted regulatory information, which assisted sponsors in improving the quality of their submissions. The event also highlighted the FDA’s Generic Drug User Fee Amendments (GDUFA) and its role in ensuring efficient regulatory pathways and timely access to generic medicines. This interactive forum underscored the FDA’s commitment to fostering collaboration, advancing regulatory science, and supporting the availability of high-quality generic drugs.
CONF - 05821
| Basic Information | |
|---|---|
| Conference Title | Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | Virtual |
| Conference Start Date | 10/23/2023 |
| Conference End Date | 10/24/2023 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $111,239.01 |
| Total number of individuals whose travel expenses were paid by the agency | 0 |
Explanation of how the conference advanced the mission of the agency
The Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium was a significant program under the FDA/CDER Small Business and Industry Assistance (CDER SBIA) initiative within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). The symposium provided a platform for FDA to engage directly with small business owners, addressing their questions and concerns about regulatory procedures. By sharing targeted regulatory information, the event aimed to help sponsors submit more complete applications, ultimately reducing review times and facilitating first-cycle drug approvals.
At the symposium, FDA employees presented on regulatory requirements related to pharmaceutical quality for Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and Biologics License Applications (BLA). These presentations were part of the FDA’s broader mission to promote productive interaction and provide timely and accurate information to regulated domestic and international small pharmaceutical businesses. SBIA outreach activities, including events like this symposium, are strategically hosted in areas dense with small pharmaceutical businesses and encompass the generic drug, device, and biotechnology industries. This empowers small businesses to navigate FDA regulations more effectively, improving the quality of their submissions and advancing their interactions with the agency.
The conference was designed to foster one-on-one interaction and also included a virtual online format to increase accessibility and broaden the global reach of the symposium. While the event primarily targeted small pharmaceutical, device, and biologics businesses, it was widely attended by representatives from small, medium, and large companies, with participants exhibiting varying levels of expertise. By providing valuable insights and enhancing collaboration, the symposium played a critical role in supporting the FDA’s mission to ensure the development of high-quality human drug products while strengthening the relationship between the agency and the industries it serves.
| Supplemental Information | |
|---|---|
| Reference Authority |
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| Recipient | Assistant Secretary of Financial Resources (ASFR) |
| Frequency/Submission Date | Annually/ January 31st of each year |
| Distribution | Published to FDA Annual Report on Conference website |
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- Update the information in bold print to complete the General Report.
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Appendix A: All conferences expenses are an aggregate of the expenditures for each conference that occurred during the calendar year.
| # | Expense Type | Definition |
|---|---|---|
| 1 | Total Agency Cost (see cost and attendee | Amount FDA spent on conferences |
| 2 | Total FDA Cost | Amount of money that the FDA spent to host conferences and to allow people to attend conferences |