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 CDER Sponsored Workshops and Meetings



International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland Meeting information and registration

Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland Meeting information and registration

PDA/FDA Pharmaceutical Ingredient Supply Chain Conference. September 10-12, 2008, Washington, D.C. Meeting information and registration

DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration

FDA Critical Path Transporter Workshop, Co-sponsored by DIA and FDA in collaboration with PhRMA, American Association of Pharmaceutical Scientists, and International Society for the Study of Xenobiotics, October 2-3, 2008, North Bethesda, MD. Meeting information and registration [External Site]


FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) 2008. August 4, 2008, Chicago, Illinois. Meeting information and registration

Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice

FDA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration

Meeting for Public Comment on the Pilot Program to Evaluate Proposed Name Submissions, June 5 and 6, 2008, Silver Spring, MD. Meeting information

FDA/DIA co-sponsored conference: Emerging Regulatory Issues in Genomic Medicine, May 21-23, Mexico City, Mexico. Meeting information and registration

Creating New Knowledge: FDA & Industry in Dialogue, May 6, 2008, Philadelphia, PA.  The seventh conference between the FDA and industry sponsored by Temple University School of Pharmacy.  Keynote Speaker: Janet Woodcock, M.D., Director, CDER.  This conference provides participants, industry, and the FDA a forum for dialogue about critical issues affecting drug development. Agenda and registration

FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 29, 2008, Dallas Texas. Meeting Information

PDA/FDA Co-Sponsored Conference Series on Quality Systems, Bethesda, MD, Nov., 1-2, 2007; Dublin, Ireland, Dec. 10-11, 2007; Beijing, China, April 21-22, 2008; Shanghai, China, April 24-25, 2008. Registration and information

2nd Annual FDA/DIA Statistics Forum, April 13-16, 2008, Marriott Bethesda, Bethesda, MD, Meeting Information.

International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information

Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Silver Spring, Maryland. Meeting information

Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop, December 6 and 7, 2007 NIH Natcher Conference Center, Bethesda, Maryland. Meeting information

Public Meeting on Essential Uses of Ozone Depleting Substances, December 5, 2007, Rockville, Maryland. Meeting Information

International Conference on Harmonization (ICH) Public Meeting October 10, 2007, Rockville MD. Meeting information

Public Meeting on Essential Uses of Ozone Depleting Substances, Rockville, MD, August 2, 2007. Meeting information

Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients, June 12-13, 2007, Washington, D.C. Meeting Information

Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges, June 25-26, 2007, Rockville, MD. Meeting information

FDA/Small Business Administration Drug Educational Forum; Public Workshop for Small Business, April 25, 2007. Meeting Information

FDA’s Pharmaceutical Quality Initiatives – Implementation of a Modern Risk-Based Approach, February 28 to March 2, 2007, Bethesda North Marriott Hotel and Conference Center, Bethesda, Maryland.  More Information 

Public Meeting on Supplements and Other Changes to an Approved Application. February 7, 2007, Rockville, MD. Meeting information

Public Meeting on Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products, National Institutes of Health, Bethesda, MD,  January 11, 2007. Meeting Information

Public workshop on issues related to the application process for seeking approval for marketed unapproved drugs, January 9, 2007. Federal Register notice [TXT] [PDF] Meeting Information

CDER Teleconference: “An Introduction to the Improved FDA Prescription Drug Labeling” Tuesday, November 7, 2006 12:30 p.m. – 2:00 p.m. Eastern time. Teleconference Information and Registration

Multiple Myloma Endpoints Meeting, October 26, 2006, Washington, DC. Meeting Information

CDER Forum for International Regulatory Authorities, September 25 - 28, 2006, Rockville, MD. Program Information and Registration

CDER Live! - Understanding FDA's New Requirements for Prescription Drug Labeling, May 9, 2006, 1 PM to 4 PM EDT. Program Information and Registration

Small Pharmaceutical Business Educational Forum Public Workshop, April 25, 2006. Meeting Information

Ovarian Cancer Endpoints - FDA and the American Society of Clinical Oncology (ASCO), with co-sponsorship by the American Association for Cancer Research (AACR), April 26, 2006, 7:30 to 5:00 pm, North Bethesda, Maryland. Meeting Information

Industry Experts, Medical Specialists and Regulators Discuss Monitoring and Evaluating Fetal Effects of Drug Exposure, May 1-3, 2006, Washington, DC Meeting Information

Public Workshop on Emerging Clostridial Disease, May 11, 2006, Atlanta, Georgia.  Meeting Information

Public Workshop on Clinical Trial End Points in Primary Brain Tumors, January 20, 2006, 8:00 a.m. to ~ 5:00 p.m. (TBD), North Bethesda, MD. Meeting Information  [PDF] [Word]

Follow-on Biologics Workshop: Scientific Issues in Assessing the Similarity of Follow-on Protein Products, New York City, NY, December 12-14, 2005.  Meeting Information

2005 FDA cGMP China Training Program, December 5-7, Bejing, China.
Program Information

Public Hearing on CDER's Current Risk Communication Strategies for Human Drugs, December 7-8, 2005  Public Hearing Information

Public Hearing on Direct-to-Consumer Promotion of Medical Products, November 1 and 2, 2005, Washington, DC 20594.  Public Hearing Information.

Electronic Common Technical Document (eCTD) Tutorial,  Thursday, October 20, 2005, Rockville, MD. Information and Registration

Overview of the ECG Warehouse and Review Process: Public Workshop, September 30, 2005,  Rockville, Maryland.  Workshop Information.

Public Meeting for Levothyroxine Sodium Therapeutic Equivalence, May 23, 2005, Washington, DC.

CDER Live! - Satellite video conference: "The CDER Drug Safety Initiative," May 20, 2005. Co-sponsored by DIA and FDA. The archived webcast will be available after 5:00 pm Eastern Time, on Saturday, May 21, 2005. Archived webcast (No password is required).

Small Business Drug Educational Forum Public Workshop, May 11, 2005.  Meeting Information and Registration

Electronic Common Technical Document (eCTD) Workshop, Friday, April 22, 2005. Workshop Agenda and Presentations

Public Hearing: Use of Color on Pharmaceutical Product Labels, Labeling and Packaging.   March 7, 2005, NIH Campus, Bethesda, MD.  Notices of participation are due February 11, 2005. Meeting Information [TXT] [PDF];  Agenda and Presentations; Meeting transcript [Word] or [PDF]

Follow-on Protein Pharmaceuticals, February 14-16, 2005, Arlington, VA.  Meeting Information

Scientific Considerations Related to Developing Follow-On Protein Products
Date and Time
Meeting Information and Presentations

Evaluating Drug Names for Similarities: Methods and Approaches, Public Meeting (name changed from "Minimizing Medication Errors - Evaluating the Drug Naming Process"). June 26, 2003, The Renaissance Washington DC Hotel. Meeting Information; Meeting Agenda

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Last updated: September, 18, 2008

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