Recent And Upcoming FDA Advisory
Meetings
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|
Topic
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Advisory
Committee
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Date
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Research updates from
the Center for Biologics Evaluation and Research's
Laboratory of Cellular Hematology and Laboratory of
Biochemistry and Vascular Biology
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Blood Products
|
April 12
|
|
Revising
bioequivalence approaches for critical dose drugs and
the use of partial area under the curve to evaluate
ANDAs for products with complex pharmacokinetic
profiles
|
Pharmaceutical Science
and Clinical Pharmacology
|
April 13
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|
Revising
bioequivalence approaches through a limitation on point
estimates; preventing failure of a marketed product to
meet stability specifications through the expiration
date; addressing the regulatory challenges of
drug-induced phospholipidosis
|
Pharmaceutical Science
and Clinical Pharmacology
|
April 14
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|
Acura Pharmaceuticals'
Acurox (oxycodone HCl and niacin) tablets
for relief of moderate to severe pain, and the results
of studies evaluating the addition of niacin to reduce
the misuse of oxycodone
|
Anesthetic and Life
Support Drugs and Drug Safety and Risk
Management
|
April 22
|
|
The World Health
Organization's NDA for artesunate rectal suppositories
for initial treatment of acute malaria patients
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Anti-Infective
Drugs
|
April 29
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|
Public meeting to
nominate voting and non-voting consumer representatives
to FDA advisory committees and panels
|
|
April 30
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|
Questcor
Pharmaceuticals's H.P. Acthar Gel
(repository corticotropin injection) for infantile
spasms
|
Peripheral and Central
Nervous System Drugs
|
May 6
|
|
The unexpected finding
of DNA originating from porcine circovirus type 1 in
Rotarix, a GlaxoSmithKline vaccine
against rotavirus gastroenteritis in infants; advanced
analytical detection methods for the characterization
of cell substrates, viral seeds and other biological
materials used in the production of viral
vaccines
|
Vaccines and Related
Biological Products
|
May 7
|
|
NicOx's nonsteroidal
anti-inflammatory drug naproxcinod for the treatment of
the signs and symptoms of osteoarthritis
|
Arthritis Drugs and
Drug Safety and Risk Management
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May 12
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|
Theratechnologies'
Egrifta (tesamorelin) for reduction of
excess visceral abdominal fat in HIV-infected patients
with lipodystrophy
|
Endocrinologic and
Metabolic Drugs
|
May 27
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|
MedImmune's
motavizumab to prevent serious lower respiratory tract
disease caused by respiratory syncytial virus in
high-risk children
|
Antiviral Drugs
|
June 2
|
|
Novartis'
Gilenia (fingolimod hydrochloride) to
treat relapsing forms of multiple sclerosis
|
Peripheral and Central
Nervous System Drugs
|
June 10
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