Drugs

Meetings, Conferences, & Workshops (Drugs)

The following are meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER):

Upcoming 

  • The FDA, the Critical Path Institute (C-Path) and the Burroughs Wellcome Fund (BWF) are co-sponsoring the “First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates” – October 28 and 29, 2014 – FDA White Oak Campus – Great Room 1503 A. We would like to invite you all to participate in this workshop on October 28 and 29, 2014. Meeting Information
  • Development and Regulation of Abuse-Deterrent Opioid Medications; Public Meeting, October 30-31, 2014, Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, MD 20910. Meeting information
  • Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD. Meeting information
  • FDA Outreach to the Pediatric Cancer Advocacy Community, November 18, 2014, FDA White Oak Campus, Bldg. 31 The Great Room A, Silver Spring, MD. Meeting information

Past

    • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. Meeting information 
    • FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014; September 18-19, 2014, Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information
    • FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
    • Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
    • PDA/FDA Joint Regulatory Conference and TRI Courses-Connecting Regulatory, Quality, Science & Compliance: Assuring Customer-Focused Outcomes Throughout the Product Lifecycle; September 8-10, 2014, Renaissance Hotel, Washington, D.C.  Meeting Informationdisclaimer icon
    • Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014, The DoubleTree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910. Meeting Information
    • Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments. August 11, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting Information
    • Regulation of Nonprescription Drug Products – Question and Answer Sessions. August 4-5, 2014. Meeting Information
    • FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2014, June 16-17, 2014. Meeting Information
    • Public Meeting on Inborn Errors of Metabolism Patient-Focused Drug Development, June 10, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction. June 9, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503, Silver Spring, MD. Meeting Information.
    • Third Annual ISPE/FDA Current Good Manufacturing Practices Conference, June 2 – 4, 2014, Hilton Baltimore, 401 W. Pratt Street, Baltimore, MD. Meeting Information
    • Public Workshop: “Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.” Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop, June 3, 2014 White Oak Campus, Building 2, Room 2047, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Meeting Information.  
    • Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments, May 28-29, 2014, FDA White Oak Campus, Bldg. 31, The Great Room (Rm. 1503), Silver Spring, MD. Meeting information
    • Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics, May 19-20, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • Public Workshop: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format, May 8-9, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • Public Meeting on Pulmonary Arterial Hypertension Patient-Focused Drug Development, May 13, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • FY 2014 Regulatory Science Initiatives Part 15 Public Meeting, May 16, 2014, FDA White Oak Campus, Bldg 31, The Great Room, Silver Spring, MD. Meeting information
    • Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907, April, 1, 2014. FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • 2014 GDUFA and You Conference, March 27-28, 2014, Hilton Orlando, Lake Buena Vista, FL. Meeting Information
    • Rescheduled Public Meeting on Fibromyalgia Patient-Focused Drug Development, March 26, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information
    • Food and Drug Administration/Xavier University PharmaLink Conference—Leadership in a Global Supply Chain, March 19-20, 2014, Xavier University, 3800 Victory Pkwy.,Cincinnati, OH 45207. Meeting information
    • Public Workshop: Application of Physiologically –Based Pharmacokinetic Modeling to Support Dose Selection, March 10, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503B and C, Silver Spring, MD.  Meeting Information
    • Over-the-Counter Ophthalmic Drug Products – Emergency Use Eyewash Products; Announcement of Public Hearing; Request for Comments, March 7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    •  Public Workshop:  Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone HealthMarch 4, 2014, Pooks Hill Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Meeting Information  

      Unfortunately, due to the extraordinary weather circumstances in the DC metropolitan area the ADEPT workshop scheduled for Tuesday, March 4, 2014 in Bethesda, MD, is postponed indefinitely. For more information, please see Meeting Information.

    • IOM/FDA Public Workshop: Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks, February 12-13, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting Information
    • Public Meeting on Sickle Cell Disease Patient-Focused Drug Development, February 7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information 
    • Nanomaterial Drug Products: Current Experience and Management of Potential Risks, January 14-15, 2014, USP Meeting Center, 12601 Twinbrook Parkway, Rockville, MD 20852. Meeting Information
    • Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases, January 6-7, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    • Public Meeting on Fibromyalgia Patient-Focused Drug Development, December 10, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503 B and C), Silver Spring, MD. Meeting information
    • Medical Gas Regulation Review; Announcement of Public Meeting, December 6, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    • Public Meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions, November 25, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503), Silver Spring, MD 20993. Meeting Information 
    • FDA's Clinical Investigator Training Course, November 12-14, 2013, The Holiday Inn, College Park, MD 20740. Meeting information and registration disclaimer icon
    • Public Workshop on Clinical Trial Design for Intravenous Fat Emulsion, October 29, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503A), Silver Spring, MD 20993. Meeting Information
    • Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II), October 21 - 22, 2013, National Institutes of Health, Natcher Auditorium, Building 45, Bethesda, MD, 20892. Meeting Information
    • Public Workshops on Proactive Compliance, Process Validation and Contract Manufacturing Operation, October 7-10, 2013, Hyatt Regency New Brunswick, New Brunswick, NJ 08901. Meeting Information
    • Abuse Deterrent Formulation Science Meeting, September 30-October 1, 2013, Bethesda North Marriott Conference Center, Bethesda, MD.  Meeting information
    • FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2013, September 25-26, 2013. Meeting information.
    • Public Meeting on Narcolepsy Patient-Focused Drug Development, September 24, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503A), Silver Spring, MD. Meeting information 
    • Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (NAFLD), September 5-6, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503), Silver Spring, MD 20993. Meeting Information
    • Clinical Development Programs for Opioid Conversion; Public Workshop; Request for Comments, July 29, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    • Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies, July 25-26, 2013, FDA White Oak Campus, Building 31 (Great Room - 1503), Silver Spring, MD.  Meeting information
    • Public Workshop on Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study, July 23, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503), Silver Spring, MD. Meeting Information
    • CDER Forum for International Drug Regulatory Authorities, June 17, 2013, College Park, MD. Meeting information
    • Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research, June 14, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503A), Silver Spring, MD. Meeting information 
    • CDER Forum for International Drug Regulatory Authorities, June 17-21, 2013, College Park, MD. Meeting information
    • Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting; Request for Comments,  June 21, 2013, FDA White Oak Campus, Bldg. 31, (Rm 1503), Silver Spring, MD. Meeting information
    • Public Meeting on Lung Cancer Patient-Focused Drug Development, June 28, 2013, FDA White Oak Campus, Bldg. 31 (Rm 1503 B and C), Silver Spring, MD. Meeting information
    • Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA, July 12, 2013, FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31, the Great Room (Rm. 1503), Silver Spring, MD. Meeting information
    • FDA Public Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer, May 5, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information
    • FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information
    • FDA Public Workshop, Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop, March 22, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information

    • Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Acute Myeloid Leukemia (AML), March 4, 2013, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information
    • Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL), February 27, 2013, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503B, Silver Spring, MD. Meeting information
    • Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing, February 25, 2013, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503B, Silver Spring, MD. Meeting information
    • CDER Small Business Webinar on Drug Master Files (DMFs) under Generic Drug User Fee Amendments (GDUFA) – February 11, 2013 (Makeup date from January 28, 2013).
      Meeting Information
    • Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy: Public Workshop; Request for Comments, February 11-12, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    • Impact of Approved Drug Labeling on Chronic Opioid Therapy Part 15 Meeting, February 7-8, 2013, Bethesda, MD. Meeting information
    • Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing, February 4-5, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
    • FDA Webinar: New Draft Guidance on "FDA Guidance for Industry Webinar on Draft Guidance Vaginal Microbicides: Development for the Prevention of HIV Infection" - January 22, 2013. Meeting Information
    • Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health, December 18, 2012, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information 
    • FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing, December 17, 2012, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information
    • Public Meeting on Antiseptic Patient Preoperative Skin Preparation Products, December 12-13, 2012 Silver Spring, MD. Meeting Information
    • CDER Small Business Webinar: Generic Drug User Fee Amendments of 2012 (GDUFA) - Self-identification Requirement - Discussion and Demonstration, November 19 & 20, 2012. Meeting Information
    • CDER Forum for International Drug Regulatory Authorities, November 5-9, 2012, College Park, MD. Meeting information
    • FDA Meeting, Solutions for Study Data Exchange Standards, November 5, 2012 , FDA White Oak Campus Bldg 31, Silver Spring, MD. Meeting Information
    • CDER Small Business Webinar on the Generic Drug User Fee Amendment (GDUFA) – User Fees and More, October 22, 2012 Meeting Information
    • Medical Countermeasures (MCM) for a Burn Mass Casualty Incident, September 27-28, 2012, Silver Spring, MD. Meeting information
    • Generic Drug User Fee Amendments of 2012 (GDUFA) Public Meeting, September 21, 2012, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 2, Room 2047, Silver Spring, MD. Meeting information
    • Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next?, September 20, 2012, The Westin Washington D.C.. City Center, 1400 M Street NW Washington, DC. Meeting information and registration
    • FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012, September 19-20, 2012, Washington Marriott Wardman Park, Washington, DC. Meeting Information
    • Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS), September 13, 2012, Teleconference. Meeting information
    • Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop, September 10-11, 2012, Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD. Meeting information
    • Issues in the Design of Clinical Trials of Antibacterial Drugs for the Treatment of Non-Cystic Fibrosis Bronchiectasis; Public Workshop, September 7, 2012, 8777 Georgia Ave., Silver Spring, MD. Meeting information
    • FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2012, June 19-20, 2012 Meeting Information
    • Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge, Public Workshop, June 7, 2012, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, The Great Room (Room 1503), Silver Spring, MD. Meeting information
    • Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop, May 30-31, 2012, Natcher Auditorium, Natcher Conference Center, NIH Campus, 45 Center Drive, Bethesda, MD. Meeting information
    • Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting, May 14, 2012, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Conference Center, the Great Room 1503 A, Silver Spring, MD. Meeting information
    • CDER Small Business Webinar on Building Quality into Clinical Trials – an FDA Perspective, May 14, 2012 Meeting Information 
    • Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments, May 11, 2012, FDA White Oak Campus, Great Room, Bldg. 31, Rm. 1503, 10903 New Hampshire Ave., Silver Spring, MD. Meeting information
    • Clinical Development Programs for Sedation Products Public Workshop, May 3, 2012, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Conference Center, the Great Room 1503 A, Silver Spring, MD. Meeting information
    • Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments; Public Workshop, April 12, 2012, FDA White Oak Campus Building 31, 10903 New Hampshire Avenue, Silver Spring, MD. Meeting information
    • CDER Small Business Webinar on the Guidance for Industry - Time and Extent Applications for Nonprescription Drug Products (2011), April 16, 2012 Meeting Information
    • FDA/ASCO Public Workshop on Minimal Residual Disease,  April 18, 2012, FDA White Oak Campus Building 31, 10903 New Hampshire Avenue, Silver Spring, MD.  Meeting Information Registration: There is no registration fee for the public workshop. To register electronically, please use the following website: Breast Cancer Workshopdisclaimer icon
    • CDER Forum for International Drug Regulatory Authorities, April 16-20, 2012, College Park, MD. Meeting information
    • Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice and Human Subject Protection Public Hearing, April 23-24, 2012, FDA White Oak Campus, 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, MD. Meeting information
    • FDA Public Workshop on Developing Animal Models of Pregnancy to Address Medical Countermeasures for Influenza, April 30 - May 1, 2012, FDA White Oak Campus Bldg 2, Silver Spring, MD. Meeting Information
    • Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs, March 22-23, 2012, FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD. Meeting information
    • CDER Small Business Webinar on FDAs Medical Countermeasures initiative (MCMi) and You, March 19, 2012 Meeting Information
    • CDER Small Business Combination Products Webinar, February 28, 2012 Meeting Information
  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments. September 5, 2014. Meeting Information

 

Page Last Updated: 10/23/2014
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