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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 

  • 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 
  • CDER Small Business Webinar on the Generic Drug User Fee Amendment (GDUFA) – User Fees and More, October 22, 2012 Meeting Information
  • DIA/FDA: Revitalizing Productivity in Drug Development, October 23-24, 2012, 5151 Pooks Hill Road, Bethesda, MD. Meeting information and registration disclaimer icon
  • The Regulatory Convergence, October 26–30, 2012, Seattle, WA. Meeting information and registration disclaimer icon
  • FDA Meeting,  Solutions for Study Data Exchange Standards, November 5, 2012 ,  FDA White Oak Campus Bldg 31, Silver Spring, MD. Meeting Information   
  • CDER Forum for International Drug Regulatory Authorities, November 5-9, 2012, College Park, MD. Meeting information
  • FDA's Clinical Investigator Training Course, November 13-15, 2012. College Park, MD. This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the scientific, regulatory and ethical aspects of clinical trials. They include discussion of non-clinical, early clinical, and phase 3 studies, issues in the design and analysis of trials, safety and ethical considerations and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Meeting information and registration disclaimer icon 
  • PDA Pharmaceutical Quality Systems (ICHQ10) Conference, November 15-16, 2012
    Meeting Information disclaimer icon
  • 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

 

Past

  • 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

  • CDER Small Business Electronic Documentation Webinar, January 23, 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
  • Safe Use Initiative; Public Workshop, November 16-17, 2010, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Maryland. Meeting information and presentations
  • Guidance for Industry: Animal Models—Essential Elements to Address Efficacy Under the Animal Rule, November 5, 2010, FDA White Oak Complex, 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Maryland. Meeting information and presentations
  • Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting, November 2-3, 2010, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Maryland. Meeting information
  • Public Workshop: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products, October 26-27, 2010, Arlington, VA. Meeting information
  • Generic Pharmaceutical Association (GPhA)/FDA 2010 Fall Technical Conference, October 20-21, 2010, Bethesda. MD. Meeting information and presentations
  • Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Regional Public Meeting, October 13, 2010, Washington Theater at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting Information and presentations 
  • CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process, October 8, 2010, National Labor College (NLC), George Meany Campus, Silver Spring, MD.  Meeting information and presentations
  • Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing, September 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland. Meeting information and presentations
  • Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis; Public Workshop, September 23-24, 2010, Crowne Plaza Hotel, 8777 Georgia Avenue, Silver Spring, Maryland 20910. Meeting information
  • Generic Drug User Fee; Public Meeting; Request for Comments, September 17, 2010, Hilton Washington DC/Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. Meeting information and presentataions
  • FDA Orphan Drugs Workshops, February 25-26, 2010, Claremont, CA; August 3-4, 2010, Minneapolis, MN. Meeting Brochure (PDF - 91 KB)
  • Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public Workshop, August 2-3, 2010. Meeting information
  • Risk Evaluation and Mitigation Strategy (REMS) Public Meeting, July 27-28, 2010, FDA White Oak Campus, Silver Spring, Maryland. Meeting information and archived webcast
  • Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop, July 26-27, 2010. Meeting information
  • Development of Articles for Rare Diseases, FDA White Oak Campus, Silver Spring, Maryland, June 29-30, 2010. Meeting information
  • Issues in the Development of Medical Products for the Prophylaxis/Treatment of Acute Antibody Mediated Rejection (AMR) in Kidney Transplant Recipients; Public Workshop, June 28-29, 2010. Meeting information
  • Public Workshop: Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors, June 24-25, 2010, Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. Meeting information
  • FDA/Xavier University Global Outsourcing Conference, June 14-16, 2010 Xavier University, 3800 Victory Parkway, Cincinnati, OH 45207. Meeting information
  • International Conference of Harmonization Regional Public Meeting, Wednesday, May 5, 2010, Rockville, Maryland. Meeting information
  • Public Hearing on Expanded Access of Direct-Acting Antiviral Agents (DAAs) for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need, April 30, 2010, Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852.  Meeting information
  • 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Presentations
  • Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, November 12 and 13, 2009. Meeting information and presentations
  • CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process, Public Workshop, October 15, 2009, 5100 Paint Branch Parkway, College Park, MD 20740. Auditorium 1A003. Meeting information and presentations
  • Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland
  • CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, Maryland.
  • Educating the Public About Removal of Essential-Use Designation for Epinephrine, Public Workshop, September 25, 2009, FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, 5600 Fishers Lane, Rm 1066, Rockville, Maryland 20852
  • Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Public Workshop, September 24-25, 2009, Gaithersburg, MD 20877. Meeting information
  • FDA, Issues in the Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop, September 1-2, 2009
  • Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop, July 29, 2009 and July 30, 2009, Silver Spring, Maryland.  Meeting Information
  • Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry, May 12-13, 2009.  Meeting Information
  • Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop; April 18, 2009, Washington, DC.  Meeting Information and presentations
  • Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland. Meeting Information
  • Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting Information

 

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