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Clinical Drug Trials
October 2004
BNA's Web Watch is prepared by Laura
Gordon-Murnane. E-mail suggestions for future weekly topics
always welcome.
Federal Government
Pending Legislation
(S.
2933) Require prescription drug and medical device manufacturers
to register clinical trials of their products in a public database
before they begin testing and then report the results
(HR
5252) House Version of (Senate bill S2933).
Congressional Hearings
House Energy and Commerce Committee
FDA's
Role in Protecting the Public Health: Examining FDA's Review of
Safety & Efficacy Concerns in Anti-Depressant Use by Children
- Subcommittee on Oversight and Investigations September 23, 2004
Panel I
Dr. Andrew Mosholder, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Panel II
Dr. Robert Temple, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dr. Thomas Laughren, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dr. James Knudsen, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dr. Paul Seligman, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dr. Tarek Hammad, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Committee on Energy and Commerce – Subcommittee on
Oversight and Investigations Publication and Disclosure
Issues in Anti-Depressant Pediatric Clinical Trials September 9,
2004
Dr.
Janet Woodcock M.D.
Acting Deputy Commissioner for Operations
U.S. Food and Drug Administration, Department of Health and Human
Services
Rockville, MD, 20857
Dr.
Richard Gorman M.D., FAAP
American Academy of Pediatrics
Dr.
David E. Wheadon, M.D.
Senior Vice President
U.S. Regulatory Affairs
GlaxoSmithKline
Dr.
Cathryn M. Clary M.D.
Vice President, U.S. Medical
Neuroscience and Customer and Market Development Pfizer Global Pharmaceuticals
Pfizer Inc.
235 E 42nd Street
New York, NY, 10017
Dr.
Ronald N. Marcus M.D.
Executive Director
Neuroscience Global Clinical Development Pharmaceutical Research
Institute
Bristol-Myers Squibb Company
Dr.
Lawrence S. Olanoff
Executive Vice President
Forest Laboratories, Inc.
Mr.
Patrick J. Osinski, Esq.
Organon USA Inc.
Ms.
Caroline Loew, Ph.D.
Vice President, Scientific and Regulatory Affairs
Pharmaceutical Research and Manufacturers of America
Senator Charles Grassley
Grassley
Seeks Complete Information from Food and Drug Administration
Grassley
asks drug makers what they told the FDA about anti-depressants and
suicide among young people
Grassley
Questions FDA’s Handling of Research on Antidepressants, Suicide
(March 25, 2004)
Health and Human Services – Inspector General Office
The
Final Compliance Program Guidance for Pharmaceutical Manufacturers
("OIG Guidance") was issued in April 2003 by the Department
of Health and Human Services Office of Inspector General ("OIG").
Health and Human Services – National Institutes of
Health
ClinicalTrials.gov
FDA
Good
Clinical Practice in FDA-Regulated Clinical Trials
Guidance
for Industry and Clinical Investigators. The Use of Clinical
Holds Following Clinical Investigator MisconductU.S. Department
of Health and Human Services Food and Drug Administration Center
for Biologics Evaluation and Research (CBER) Center for Drug Evaluation
and Research (CDER) September 2004
FDA Advisory Committee Meetings
The Psychopharmacologic Drugs Advisory Committee and the Pediatric
Advisory Committee
Briefing
Materials and Meeting September 14-15
Suicidality
in Clinical Trials for Antidepressant Drugs in Pediatric Patients
States
New York – Attorney General – Elliot Spitzer
Settlement
Sets New Standard For Release Of Drug Information
Glaxo to Establish "Clinical Trials Register" with Information
on All Company Drugs
Consent
Order
Assurance
of Discontinuance with Appendices
New York State Psychiatric Association, Inc. Press Release
FOREST
LABS TO ESTABLISH CLINICAL TRIALS REGISTRY
Assurance
of Discontinuance Between Forest Laboratories and the
Attorney General of the State of New York
STATEMENT
REGARDING DECISION BY GLAXOSMITHKLINE TO POST SUMMARIES OF CLINICAL
TRIAL RESULTS
MAJOR
PHARMACEUTICAL FIRM CONCEALED DRUG INFORMATION
Complaint
Statement
by the New York State Ps | 
