CDER Calendar

Calendar of CDER Advisory Committee Meetings

Participants should verify the times and locations of meetings and events listed on this page. Additional meetings and events appear on the FDA Meetings Page.

• List of Tentative Advisory Committee Meetings
• FDA Advisory Committees Telephone Information Line
• Human Drug Advisory Committees: Comprehensive information about CDER's Advisory Committees, including:  transcripts, committee rosters, charters, agendas; a list of CDER Advisory Committee Staff; and committee nomination information.

 Center for Drug Evaluation and Research
Food and Drug Administration
Advisors and Consultants Staff

January, 2004 Meetings

No Meetings Scheduled

February, 2004 Meetings

Psychopharmacologic Drugs Advisory Committee and the
Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee

Date and Time: The meeting will be held on February 2, 2004, from 8 a.m. to 5 p.m.

Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Avenue, Bethesda, MD.  The hotel phone number is  301-652-2000.

Contact Person: Anuja Patel, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane  Rockville, MD 20857, 301/827-7001, Fax: 301/827-6776 or email: patelA@cder.fda.gov,  

Agenda: The Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will discuss reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various anti-depressant drugs in pediatric patients with major depressive disorder (MDD).  The committee will consider optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee will also consider further research needs to address questions on this topic.

Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee. 

Date and Time:  February 3, 2004, from 9 a.m. to 4:45 p.m. and February 4, 2004, from 8 a.m. to 12 noon. 

Location: CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. 

Contact Person:  Thomas H. Perez, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, or by e-mail: perezt@cder.fda.gov.  

Agenda:  On February 3, 2004, the subcommittee will meet between 9 a.m. and 10:15 a.m., and the agency will report to the subcommittee on Adverse Event Reporting as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA).  The products to be reported during this portion of the meeting include:  Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin), and Navelbine (vinorelbine).  Following this, from approximately 10:30 a.m. to 4:45 p.m., the subcommittee will discuss the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population.  On February 4, 2004, the subcommittee will meet between 8 a.m. and 12 noon to continue the discussion on the use of imaging drugs in conjunction with cardiac imaging procedures in the pediatric population. 

Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee 

Date and Time: February 26 and 27, 2004, from 8 a.m. to 5 p.m. 

Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.  

Contact Person: Shalini Jain, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane Rockville, MD 20857, 301-827-7001, e-mail: jains@cder.fda.gov

Agenda: The committee will discuss the following topics: (1) The effectiveness of the isotretinoin risk management program for the prevention of fetal exposure to ACCUTANE and its generic equivalents, and (2) consider whether changes to this isotretinoin risk management program would be appropriate.