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U.S. Department of Health and Human Services

Drugs

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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

  • 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: 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
  • 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

Past

  • 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

  • Hepatotoxicity Special Interest Group Conference, March 20-21, 2013, Marriott Inn & Conference Center, University of Maryland University College, East Hyattsville, MD. Meeting information and registration disclaimer icon

  • 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
  • Pharmaceutical Quality Systems (ICHQ10) Conference, November 15-16, 2012 Meeting Information disclaimer icon
  • FDA's Clinical Investigator Training Course, November 13-15, 2012. College Park, MD. Meeting information and registration disclaimer icon 
  • 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
  • The Regulatory Convergence, October 26–30, 2012, Seattle, WA. Meeting information and registration disclaimer icon
  • DIA/FDA: Revitalizing Productivity in Drug Development, October 23-24, 2012, 5151 Pooks Hill Road, Bethesda, MD. Meeting information and registration disclaimer icon
  • CDER Small Business Webinar on the Generic Drug User Fee Amendment (GDUFA) – User Fees and More, October 22, 2012 Meeting Information
  • DIA/FDA Industry PDUFA V Conference, October 18-19, 2012, Hilton Crystal City at Washington Reagan National Airport 2399 Jefferson Davis Hwy. Arlington, VA. Meeting information and registration disclaimer icon 
  • Medical Countermeasures (MCM) for a Burn Mass Casualty Incident, September 27-28, 2012, Silver Spring, MD. Meeting information
  • FDA/Xavier University Global Outsourcing Conference, September 24-26, 2012,  Xavier University, 3800 Victory Pkwy., Cincinnati, OH.  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
  • DIA/FDA: Biosimilars Conference: Guidances, Science, and BsUFA, September 12-13 2012, Washington Marriott Wardman Park, Washington, DC. Meeting information and registration disclaimer icon
  • 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: http://www.zoomerang.com/Survey/WEB22EJ4HRZLW9disclaimer 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

  • Generic Drug User Fee (GDUF) Public Meeting, December 19, 2011, FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD. Meeting information.
  • CDER Small Business Webinar on PDUFA, December 19, 2011 Meeting Information
  • FDA Clinical Investigator Training Course, November 7-9, 2011.  Meeting information
  • Introduction to the Drug Master File (DMF) Webinar, November 14, 2011 Meeting Information
  • Review and Qualification of Clinical Outcome Assessments; Public Workshop, October 19, 2011, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 Conference Center, Silver Spring, MD. Meeting information
  • CDER Forum for International Drug Regulatory Authorities, October 17-21, 2011, College Park, MD. Meeting information
  • Overview of the Office of Orphan Products Development: Incentives for Rare Diseases Webinar, October 18, 2011. Meeting Information
  • FDA/Xavier University Global Outsourcing Conference, October 3-5, 2011, Xavier University, Cincinnati, OH. Meeting information
  • Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop, September 26, 2011, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (Great Room), Silver Spring, MD. Meeting information
  • CDER Small Business Assistance Industry Workshop: Clinical Trials and Electronic Submissions, September 26-27, 2011, Los Angeles, CA and September 28-29, 2011, San Francisco, CA.  Meeting information
     
  • Sunscreens Marketed Under the OTC Monograph System Webinar - September 19, 2011. Meeting Information
  • Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop, September 8-9, 2011, 8777 Georgia Ave., Silver Spring, MD. Meeting information
  • Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media; Public Workshop, September 7, 2011, 8777 Georgia Ave., Silver Spring, MD. Meeting Information
  • Human Drug Export Compliance Webinar - July 14, 2011. Meeting Information 
  • Import of Human Drugs and Human Drug Components Webinar - June 16, 2011. Meeting Information
  • Preparation for ICH Steering Committee and Expert Working Group Meetings in Cincinnati, Ohio; Regional Public Meeting, May 19, 2011, Washington Theater room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting information 
  • Overview of the Drug Registration and Listing System (DRLS & eDRLS) Webinar – May 12, 2011. Meeting Information
  • Generic Drug User Fee; Public Meeting; Request for Comments; May 10, 2011, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103, and 4105, Silver Spring, MD 20993-0002. Meeting information
  • FDA/CDER/DDI/DDMAC Webinar - Bad Ads Program Webinar - April 28, 2011. Meeting Information
  • CDER Small Business Assistance, Clinical Trials Forum - April 21, 2011, FDA White Oak Campus, Building 31, Room 1503 - Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Meeting information and registration
  • CDER Forum for International Drug Regulatory Authorities, April 4-8, 2011, College Park, MD. Meeting information
  • FDA/CDER/DDI Webinar - Small Business Assistance - CDER 101, March 14, 2011. Meeting information 
  • Preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging; Public Meeting, March 2, 2011, FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Maryland 20993. Meeting information
  • Generic Drug User Fee Stakeholder Update, February 23, 2011, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 32, Room 1325, Silver Spring, Maryland 20993. Meeting information
  • Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Public Workshop, February 15-16, 2011, FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, room 1503, Silver Spring, MD 20993. Meeting information

 

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