2025 Report on FDA-Held Conferences With Expenses Over $100,000
General Report
The Food and Drug Administration (FDA) hosted, sponsored, or co-sponsored 2 conferences with expenditures greater than $100,000 this fiscal year. The FDA funded travel expenses for 37 FDA employees associated with these conferences, consisting of 37 Federal employees and 0 Non-Federal employees. FDA was the only conference sponsor for these conferences, and conference topics included, but were not limited to Meeting Patient Needs Through the Years, Introduction to Water Systems, Best Practices for Generic Drug Labeling, etc. All conferences funded and attended followed the applicable Federal authorities, policies and procedures. Furthermore, all conferences helped advance the FDA’s mission by strengthening regulatory understanding, improving compliance with statutory and quality requirements, and supporting the development, oversight, and availability of safe, effective, and high-quality drug products. Through targeted education, direct engagement with regulated industry and stakeholders, and dissemination of accurate and consistent regulatory information, these conferences enhanced industry’s ability to meet FDA requirements, improved the quality of submissions and manufacturing practices, reduced regulatory inefficiencies, and supported patient access to reliable medications, thereby directly advancing the Agency’s public health mission.
Narrative Report
See below for a summation of all conference expenditures for FY 2025.
| Total Conference Net Expenses (in dollars) | $942,208.30 |
|---|
Conference Report
CONF - 08413
| 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 Road Rockville, Maryland 20852 |
| Conference Start Date | 08/27/2025 |
| Conference End Date | 08/28/2025 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $783,100.16 |
| Total number of individuals whose travel expenses were paid by the agency | 37 |
Explanation of how the conference advanced the mission of the agency
The year-end conference advanced the mission of the agency by engaging outsourcing facility staff and associated stakeholders on issues related to drug production, regulatory compliance, and FDA oversight approaches for outsourcing facilities. The conference educated outsourcing facilities, compounders interested in becoming outsourcing facilities, and federal and state regulators on emerging trends, compounding best practices, and statutory requirements under Section 503B of the Federal Food, Drug, and Cosmetic Act, including Current Good Manufacturing Practice (CGMP) requirements. Through FDA-led sessions and discussions, the conference supported the development of a more reliable supply of compounded drugs needed by hospitals, clinics, and other health care providers, thereby supporting patient access to medications. The conference served as an education and engagement effort to address ongoing quality and safety challenges within the outsourcing facility sector, which remains a young domestic industry with persistent compliance issues identified during inspections. By providing accurate, consistent regulatory information and fostering direct engagement between FDA and industry participants, the conference strengthened industry understanding of FDA requirements, improved the ability of outsourcing facilities to meet statutory mandates, enhanced the quality of compounded drugs, and promoted a common understanding of regulatory expectations among all stakeholders, directly supporting the agency’s public health 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 U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that made biologics, medicines, and foods more effective, safer, and more affordable; and helping the public access accurate science-based information for drug products and foods. The FDA’s mission is to ensure the safety purity, potency, and effectiveness of regulated products. The agency is committed to providing the public with accurate, timely and easy to understand information on agency policies, programs, and actions.
The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs were safe and effective for their intended use, met established quality standards and were 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 presented 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 fall 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. To date, the COE has held five annual conferences, with this sixth conference planned for 2025. These conferences have been very well attended and were highly rated by attendees.
There were over 950 attendees for the 2024 conference including outsourcing facilities and associated stakeholders such as: federal and state regulators, pharmacy organizations, professional organizations, hospital and health systems, patient organizations, suppliers, and regulatory consultants. This was the only existing large-scale meeting centered on outsourcing facility issues and had become a mainstay within the compounding community over its five years of existence. It enabled outsourcing facilities to engage with FDA and other stakeholders and learn about emerging trends and compounding best practices to better adhere to statutory mandates and improve the quality of compounded drugs that outsourcing facilities produce.
CONF - 08413
| Basic Information | |
|---|---|
| Conference Title | Small Business Regulatory Education for Industry Generic Drugs Forums |
| Applicable Conference Type | Scientific, FDA Hosted/Sponsored/Co-Sponsored |
| Conference Location | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road Rockville, Maryland 20852 |
| Conference Start Date | 04/09/2025 |
| Conference End Date | 04/10/2025 |
| Cost and Attendee Information | |
|---|---|
| Total agency cost of the conference | $159,108.14 |
| 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 two-day forum advanced the mission of the agency by educating the small business generic pharmaceutical industry on key elements of the generic drug development continuum and FDA regulatory expectations. Conducted as a hybrid event, the forum expanded access and engagement while supporting efficient dissemination of regulatory information. The meeting supported the agency’s mission by promoting productive interaction between FDA and regulated domestic and international pharmaceutical businesses seeking timely and accurate guidance related to the development and regulation of human drug products. As a major program element of the Small Business and Industry Assistance program, the forum enabled FDA to hear directly from small business owners regarding questions and concerns about regulatory procedures, while also allowing FDA to share targeted, consistent regulatory information. This engagement helped empower small businesses in their interactions with FDA, supported the submission of more complete applications, and contributed to improved first-cycle review outcomes and reduced review timelines. The forum further advanced the agency’s mission by fostering regulatory understanding across a broad industry audience, including small, medium, and large pharmaceutical stakeholders, thereby strengthening compliance, improving submission quality, and supporting efficient access to safe and effective generic drug products.
| Supplemental Information | |
|---|---|
| Reference Authority |
|
| 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 |
OMB-17-08 Annual Report Instructions
Information on how to effectively complete this report is provided below.
- Save a copy of the report to a repository where it will be easily accessible for future review.
- Use the Microsoft Word reporting template document (OMB M-17-08 Reporting Template) and complete all fields.
- Update the information in bold print to complete the General Report.
- Enter all applicable fields into the table to conference expenditures table to complete the Narrative Report. (See Appendix A for a list of conference expense types and corresponding definitions).
- For each additional conference, copy and paste the tables on page 2 onto a subsequent new page.
- Submit completed template to OC Web Request Client/App.
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 |