CDER Sponsored Workshops and
AAPS Workshop; Utilization of Process Modeling & Advanced Process Control in QbD Based Drug Development and Manufacturing, April 27-28, 2009, Sheraton Inner Harbor Hotel, Baltimore, MD. Meeting Information
Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, December 12, 2008, National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594. Meeting information.
PDA/FDA Pharmaceutical Ingredient Supply Chain Conference,
December 3 - 5, 2008, Coronado, California Meeting information and registration
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
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
Meeting for Public Comment on the Pilot Program to Evaluate Proposed Name Submissions, June 5 and 6, 2008, Silver Spring, MD. Meeting information
FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 29, 2008, Dallas Texas. 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’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.
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.
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,
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]
Follow-on Biologics Workshop: Scientific Issues in Assessing the
Similarity of Follow-on Protein Products, New York City, NY, December
2005 FDA cGMP China Training Program, December 5-7, Bejing, China.
Public Hearing on CDER's Current Risk Communication Strategies for Human Drugs, December 7-8, 2005 Public Hearing
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.
Public Meeting for
Levothyroxine Sodium Therapeutic Equivalence, May 23, 2005,
Small Business Drug Educational Forum Public Workshop, May 11,
2005. Meeting Information and
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]
Agenda and Presentations; Meeting
transcript [Word] or [PDF]
Follow-on Protein Pharmaceuticals,
February 14-16, 2005, Arlington, VA.
Scientific Considerations Related to Developing Follow-On Protein
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
PDF requires the free
Last updated: December 8, 2008