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FDA Links -- CDER Calendar
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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
(6/25/2009)
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Agenda for the May 27 - 28, 2009 Opioid REMS Public
Meeting
(PDF, 5/22/2009)
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Risk Evaluation and Mitigation Strategies (REMS) and
Opioid Analgesics Webinar (4/27/2009)
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Quality Risk Management –
Implementation Strategies; U.S. FDA/CDER and University of Rhode Island
College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency
Bethesda, Bethesda, Maryland.
Meeting
Information (4/20/2009)
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Public Workshop on Developing a Consolidated
Pediatric Rheumatology Observational Registry; May 12-13, 2009 (3/26/2009)
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Clinical Trial Design for
Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public
Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland.
Public Workshop
Information (updated 3/25/2009)
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3rd Annual FDA/DIA
Statistics Forum: Emerging and Strategic Issues in Drug
Development, Personalized Medicine, and a Guidance
Update, April 26, 2009, Westin Arlington Gateway,
Arlington, VA 22203.
Meeting Information (3/13/2009)
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Drug Information Association (DIA): Cardiovascular Safety, QT, and
Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt
Regency Besthesda, Bethesda, MD.
Meeting information (2/23/2009)
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Forum - Cytokine
Therapies: Novel Approaches for Clinical Indications, March 26 and 27,
2009, NYAS Conference Center, New
York City, NY.
Meeting Information
(2/12/2009)
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PQRI Workshop: Demonstrating
Bioequivalence of Locally Acting Orally Inhaled Drug Products, March
9-10, 2009, Hyatt Regency Bethesda, Bethesda, MD.
Program and registration (2/11/2009)
- FDA Small Pharmaceutical Business
Assistance Educational Forum Public Workshop, April 23, 2009.
Meeting Information and registration (2/9/2009)
- 2009 PDA/FDA Asia-Pacific Pharmaceutical
Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China.
Meeting Information and
registration (1/27/2009)
- 2009 PDA/FDA Joint Regulatory
Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW,
Washington, D.C.
Meeting Information and registration (1/27/2009)
- Public Hearing: Designating Additions to
the Current List of Tropical Diseases in the Food and Drug
Administration Amendments Act, December 12, 2008, National
Transportation Safety Board Boardroom and Conference Center, 429
L'Enfant Plaza, SW., Washington, DC 20594 (Posted: 12/10/2008)
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Meeting information
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Agenda (PDF)
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Drug Safety Oversight Board Meeting, October 16, 2008, Public Summary
(10/30/2008)
- International Conference on
Harmonization (ICH) Public Meeting, October 21, 2008, Rockville,
Maryland:
Meeting information and registration - (updated 10/17/08)
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Drug Safety Oversight Board Meeting, September 18, 2008, Public Summary
(10/3/2008)
- Public Hearing for Over-the-Counter
Cough and Cold Medications, October 2, 2008,
Beltsville, Maryland:
Meeting
information and registration (updated 9/29/2008)
- Drug Development and Drug Interactions:
Meetings:
FDA
Critical Path Transporter Workshop - (updated 9/29/2008)
- International Conference on
Harmonization (ICH) Public Meeting, October 21, 2008, Rockville,
Maryland:
Meeting information and registration - (updated 9/25/2008)
- Public Hearing for
Over-the-Counter Cough and Cold Medications, October 2,
2008, Beltsville, Maryland:
Meeting
information and registration
(8/22/2008)
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Drug Safety Oversight Board Meeting, July 17, 2008
(8/21/2008)
- DIA/FDA/PhRMA Drug Safety Conference:
Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA.
Meeting information and registration (7/28/2008)
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Drug Safety Oversight Board Meeting, June
19, 2008 (7/28/2008)
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FDA Workshop on
Approaches to Reduce Risk of Transfusion Transmitted Babesiosis in the
United States (Posted: 7/3/2008; Meeting Date: 9/12/2008)
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Drug Safety Oversight Board Meeting, April
17, 2008, Public Summary (5/13/2008)
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DA/ISPE Co-sponsored
Event: Regulatory Perspectives on Hot Topics, Regulatory Trends,
and Observations (E07), June 4-5, Washington, DC.
Meeting information and registration (5/6/2008)
- 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 (5/6/2008)
- Meeting: A Joint FDA/URI College of
Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June
30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD.
Meeting Information [PDF, External Site] (4/2/2008)
- International Conference on
Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon,
Rockville, MD, April 4, 2008.
Meeting
Information (4/1/2008)
- Updated phone number for the
FDA
Small Pharmaceutical Business Assistance Educational Forum Public
Workshop (3/17/2008)
- FDA Small Pharmaceutical Business
Assistance Educational Forum Public Workshop April 29, 2008.
Meeting Information
(3/11/2008)
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Public Workshop: Safety of Hemoglobin-Based Oxygen
Carriers (HBOCs) Meeting Date: 4/29-30/2008
(Posted 2/8/2008)
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Clinical Trial Design for
Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008,
Silver Spring, Maryland.
Meeting information
(12/21/2007)
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Adolescent Over-the-Counter (OTC) Drug Product Use: A
Public Workshop [PDF] (11/28/2007)
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CDER on CMC: 21st Century Pharmaceutical
Manufacturing and Control Strategies – A Changing Paradigm, October
15-16, 2007 Bethesda North Marriott Hotel & Conference Center.
Meeting information (9/10/2007)
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Use of Medication Guides to Distribute Drug Risk Information to
Patients, June, 2007 - Public Meeting Presentations (updated
7/13/2007)
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Public
Meeting on Essential Uses of Ozone Depleting Substances August 2, 2007,
Rockville, MD (7/6/2007)
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Drug Safety Oversight Board Meetings Public Summaries,
April 19 (7/3/2007)
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Use of Medication Guides to Distribute Drug Risk
Information to Patients, June, 2007 - Public Meeting Presentations
(6/29/2007)
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Office of Nonprescription Drugs:
Chronological List of All NDAC Meetings (1992 to Present)
(6/22/2007)
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Implementation
of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of
Pharmaceuticals: Opportunities and Challenges (updated 6/12/2007)
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Agenda [PDF]
Pharmaceutical Quality Systems 2007 - An FDA/Industry Workshop,
June 26-27, Parsippany, NJ.
Registration and information (5/21/2007)
E-08 Product Quality Lifecycle Implementation: Practical Approach to
QbD - co-sponsored by the FDA, June 6-7, 2007, Arlington, VA.
Meeting Information (4/19/2007)
Public Hearing on Use of Medication Guides to Distribute Drug Risk
Information to Patients, June 12-13, 2007.
Meeting Information (4/9/2007)
New Date: International Conference on Harmonization (ICH)
Public Meeting Thursday, May 3, 2007, Rockville, MD.
Meeting
Information (4/4/2007)
FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases:
Antibody Specificity, Potency and Testing (Posted: 2/26/2007; Meeting Date: 4/25-26/2007)
1st Annual FDA/DIA Statistics Forum (with
FDA presenters), March 5-7, 2007, Doubletree Hotel & Executive
Meeting Center, Bethesda, Maryland.
Registration and Information (2/20/2007)
DIA/FDA Co-Sponsorship Event QT Issues in Drug Development: The
Evolving Science, Practical Issues, and Regulatory Implications,
April 11-13, 2007, Washington Marriott Hotel, 1221 22nd Street NW,
Washington, DC 20037-1294.
Meeting Information (2/5/2007)
Meeting: FDA/DIA co-sponsored conference: Sharing Knowledge to Improve
clinical Drug Development and Regulatory Decisions: Data/models of
Diseases, Drugs, Placebo, Baseline, and Dropouts. January 24 and 25, 2007,
Washington, DC, Washington Marriott Hotel.
Meeting Information [External Site] (1/10/2007)
Public Meeting on Supplements and Other Changes to an Approved
Application. February 7, 2007, Rockville, MD.
Meeting information
(1/5/2007)
Multiple Myloma Endpoints Meeting, October 26, 2006, Washington, DC.
Meeting Information (10/10/2006)
Platelet
Pheresis Review Checklist: General (Posted: 9/25/2006)
Joint FDA/URI Conference - CDER on CMC: 21st Century Pharmaceutical
Manufacturing and Control Strategies – A New Paradigm, October 17-18,
2006, Reston, Virginia.
Information [PDF, external site
9/7/2006]
International Conference on Harmonization (ICH) Public Meeting, Monday,
October 2, 2006, Rockville, MD.
Meeting
information (8/8/2006)
Public
Workshop on Emerging Clostridial Disease, May 11, 2006
(6/20/2006)
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Summary of Proceedings (PDF)
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Meeting Transcript (PDF)
CDER Forum for
International Regulatory Authorities, September 25 - 28, 2006, Rockville,
MD.
Program Information and
Registration (6/15/2006)
2006 FDA/Industry Workshop:
Pharmaceutical Quality Systems, June 23,
Parsippany, NJ or July 20, Chicago, IL.
Program information and Registration [external site] (5/25/2006)
Public Workshop on Emerging Clostridial Disease, May 11, 2006.
Presentations (5/17/2006)
International Conference on Harmonization (ICH)
Public Meeting, May 8, 2006, Rockville, MD.
Meeting
Information (4/24/2006)
FDA co-sponsors a hands-on workshop on
implementing the Final Rule on the Content and Format of Prescription
Drug Labeling.
Meeting information [PDF, external site] (4/4/2006)
Creating New Knowledge: FDA & Industry in Dialogue – Wednesday,
March 29 in Philadelphia, PA. The sixth conference between the FDA and
industry sponsored by Temple University School of Pharmacy. Keynote
Speaker: Steven Galson, MD, MPH, Director, CDER. This conference provides
participants, industry, and the FDA a forum for dialogue about critical
issues affecting drug development.
Agenda and
Registration. (3/15/2006)
Ovarian Cancer Endpoints Public Workshop, April 26,
2006, North Bethesda, Maryland.
Meeting Information (PDF, 3/6/2006)
Drug Information Association (DIA) Webinar:
Physician Labeling Rule, March 21, 2006, 11:00-12:30 EST.
Meeting Program
(PDF) and
Registration [external
site] (3/1/2006)
Small Pharmaceutical Business Educational Forum
Public Workshop, April 25, 2006. (3/1/2006)
Meeting
Information
2006 FDA cGMP China Training Program, April
24-26, Beijing, China. FDA, Peking University, and ISPE are
co-sponsoring a training program to provide the latest updates from the
FDA on current regulations and guidances, and interactive training
workshops on oral solid dosage, and API manufacturing.
Program Information (from the 2005 session) (2/24/2006)
SoCRA FDA Clinical Trials Requirements and GCP Conference,
Co-sponsored with FDA, May 17 and 18, 2006 in Baltimore, MD.
More information
and Registration. [External Site] (2/7/2006)
APS Workshop on Ensuring the Supply of Qualified
Pharmaceutical Scientist Specialists in Product Development and Related
Technologies that Meet Current and Future Needs, May 1-2, 2006, Hyatt
Regency Crystal City Arlington, VA Co-Sponsored with FDA.
Program and
Registration [external site]
AAPS/FDA Third Bioanalytical Workshop: Quantitative
Bioanalytical Methods Validation and Implementation - Best Practices for
Chromatographic and Ligand Binding Assays, May 1-3, 2006, Hyatt Regency
Crystal City Arlington, VA. Program and Registration
Program and
Registration [external site]
FDA Public Workshop on Clinical Trial End Points in
Primary Brain Tumors, January 20, 2006, 8:00 a.m. to 4:00 p.m. North
Bethesda, MD.
Meeting
information (updated 1/19/2006)
Webinar: CDER Town Meeting: Current Hot Topics Regarding
eSubmissions. January 18, 2006.
Program and Registration [external site] (1/6/2006)
Webinar: The Current Implementation Status of Electronic Case
Reporting. January 19, 2006.
Program and Registration [external site] (1/6/2006)
FDA 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]
(11/22/2005)
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 (11/7/2005)
Preparation for International
Conference on Harmonization (ICH) Meetings in
Chicago, Illinois, Thursday, October 20, 2005,
Rockville, Maryland.
Meeting
information (10/7/2005)
Electronic Common Technical Document (eCTD) Tutorial,
Thursday, October 20, 2005, Rockville, MD.
Information and Registration (10/7/2005)
Public
Hearing on CDER's Current Risk Communication Strategies for Human Drugs,
December 7-8, 2005, National Transportation Safety Board Boardroom and
Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594.(10/3/2005)
Application and Validation of Genomic Biomarkers for use in Drug
Development and Regulatory Submissions, October 6-7, Bethesda, MD.
Co-sponsored by by DIA, FDA, PhRMA, BIO, & PWG.
Agenda and
Registration (PDF, 9/22/2005)
Public Hearing on Direct-to-Consumer Promotion of Medical
Products, November 1 and 2, 2005, National Transportation Safety
Board Boardroom and Conference Center, 429 L’Enfant Plaza, SW.,
Washington, DC 20594.
Public
Hearing Information (9/19/2005)
SoCRA FDA Clinical Trails Requirements and GCP Conference,
Co-sponsored with FDA, December 7 and 8, 2005 in Cincinnati, Ohio.
Information and
Registration (8/9/2005)

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