FDA Advisory Committee
Meetings - For info, visit
www.fdaadvisorycommittee.com
|
|
Topic
|
Indication/Discussion
|
Advisory
Committee
|
Date
|
|
Transkaryotic
Therapies Replagal
|
Treatment of
Fabry's disease
|
Endocrinologic & Metabolic Drugs
|
Sept.
27
|
|
Genzyme
Fabrazyme
|
Treatment of
Fabry's disease
|
Endocrinologic & Metabolic Drugs
|
Sept.
26
|
|
Osteoporosis
treatment trial design
|
Clinical
trial endpoints
|
Endocrinologic & Metabolic Drugs
|
Sept.
25
|
|
Aspirin risk
management
|
Aspirin, OTC
NSAID risk management strategies
|
Nonprescription Drugs
|
Sept.
20
|
|
Acetaminophen
risk management
|
Acetaminophen
Rx and OTC risk management strategies
|
Nonprescription Drugs
|
Sept.
19
|
|
Chronic
hepatits B drug development
|
Chronic
hepatitis B trial design
|
Antiviral
Drugs
|
Aug. 7
|
|
Gilead
adefovir dipivoxil
|
Treatment of
chronic hepatitis B
|
Antiviral
Drugs
|
Aug. 6
|
|
Pain
classification; trial design
|
Acute and
chronic pain subcategories; trial design
|
Arthritis
|
July
29-30
|
|
Bristol-Myers
Squibb Vanlev
|
Treatment of
hypertension
|
Cardiovascular & Renal Drugs
|
July
19
|
|
AstraZeneca
Atacand
|
Comparative
efficacy to Merck's Cozaar
|
Cardiovascular & Renal Drugs
|
July
18
|
|
Bristol-Myers
Squibb pravastatin/aspirin co-package
|
Reduction in
risk of cardiovascular events including death,
non-fatal MI, myocardial revascularization procedures
and ischemic stroke in patients with clinically evident
coronary heart disease
|
Cardiovascular & Renal Drugs
|
July
18
|
|
Consumer
information
|
Effectiveness
of consumer Rx drug information
|
Drug Safety
and Risk Management
|
July
17
|
|
Otitis
media
|
Clinical
trial design for studies of otitis media
|
Anti-Infective Drugs
|
July
11
|
|
World Health
Organization-sponsored artesunate
|
Emergency
treatment of malaria
|
Anti-Infective Drugs
|
July
10
|
|
TSE and CJD
transmission risk
|
Tissue
transplantation; CJD draft guidance; blood donor
deferrals
|
Transmissible
Spongiform Encephalopathies
|
June
26-27
|
|
Additional past
meetings available.
|
|
For more
information, visit www.FDAAdvisoryCommittee.comor contact Tim Wahl
at 301-664-7210 or [email protected]. Future meetings
can be viewed via live webcast or videoconference. Past
meetings are available via archived webcast or
videotape.
|
