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FDA Issues: Review & Approval of New Drugs & Other Regulatory Issues
FDA to Revisit Gay Blood Donations Policy
(March 15, 2010)
In
CDC HIV/Hepatitis/STD/TB Prevention News Update
, from
U.S. Centers for Disease Control and Prevention
The End of HIV Drug Development as We Know It?
(Feb. 18, 2010; 1:45 p.m. Pacific Time)
A blog entry from CROI 2010 by Gerald Pierone Jr., M.D.
In
The 17th Conference on Retroviruses and Opportunistic Infections
, from
The Body PRO
FDA Grants Full Approval to J&J's HIV Drug
(December 8, 2009)
In
CDC HIV/Hepatitis/STD/TB Prevention News Update
, from
U.S. Centers for Disease Control and Prevention
FDA Regulations to Improve Access to Investigational Drugs for People With HIV/AIDS, Other Illnesses
(August 13, 2009)
In
Kaiser Daily U.S. HIV/AIDS Report
, from
Henry J. Kaiser Family Foundation
HIV/AIDS Update -- New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
(August 12, 2009)
From
U.S. Food and Drug Administration
FDA Halts Reviews of Pending Ranbaxy Applications, Cites Fraudulent Lab Tests
(February 27, 2009)
In
Kaiser Daily HIV/AIDS Report
, from
Henry J. Kaiser Family Foundation
The Coming Crisis
(October 2008)
To read PDF,
click here
.
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
U.S. Patent Agency to Review Gilead's Claim on Tenofovir
(July 20, 2007)
In
CDC HIV/Hepatitis/STD/TB Prevention News Update
, from
U.S. Centers for Disease Control and Prevention
Senate Approves New Power for F.D.A. on Drugs
(May 9, 2007)
In
The New York Times
Single-Pill, Once-Daily HIV Drug Regimen Submitted for FDA Approval
(April 28, 2006)
In
Kaiser Daily HIV/AIDS Report
, from
Henry J. Kaiser Family Foundation
The Food and Drug Administration: The Process of Approval
(Fall 2004)
[Archived Article]
How medications for HIV and other diseases make it -- or fail to make it -- to the U.S. market.
To read PDF,
click here
.
In
ACRIA Update
, from
AIDS Community Research Initiative of America
Food and Drug Administration to Expedite Decision on Emtricitabine/Tenofovir Pill
(May 18, 2004)
[Archived Article]
In
Kaiser Daily HIV/AIDS Report
, from
Henry J. Kaiser Family Foundation
U.S. to Start Fast-Track Review Program for Generic HIV Drugs, Fixed-Dose Combinations
(May 17, 2004)
[Archived Article]
In
Kaiser Daily HIV/AIDS Report
, from
Henry J. Kaiser Family Foundation
Drug Development News: Fixed-Dose Combinations
(May/June 2004)
The Food and Drug Administration's fast-track approval process for fixed-dose combinations is about to bear fruit.
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
Treatment Activists Meet With the FDA
(November 2003)
[Archived Article]
Highlights of a discussion on the development and approval of new HIV medications.
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
Testimony on Accelerated Approval: September 1994
(November 2003)
[Archived Article]
Carlton Hogan's warnings about the need to study long-term drug toxicities are as poignant today as they were nine years ago.
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
FDA Discusses Clinical Trial Designs for Microbicide Research
(September 2003)
[Archived Article]
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
Roche Gets FDA OK for Improved HIV Test
(April 2003)
[Archived Article]
In
HEPP Report
, from
Brown Medical School
FDA Approves Valacyclovir for HIV-Infected Patients
(April 2003)
[Archived Article]
In
HEPP Report
, from
Brown Medical School
New Guidance on Clinical Trial Design in Developing Treatment for HIV Infection
(November 1, 2002)
[Archived Article]
From
U.S. Food and Drug Administration
Washington: Judge Voids Rules on Pharmaceutical Tests
(October 21, 2002)
[Archived Article]
In
CDC HIV/Hepatitis/STD/TB Prevention News Update
, from
U.S. Centers for Disease Control and Prevention
An Overview of the Drug Approval Process
(Summer 2002)
[Archived Article]
In
Research Initiative/
Treatment Action!
, from
The Center for AIDS
Accelerated Approval: Where Are We Now?
(Summer 2002)
[Archived Article]
In
Research Initiative/
Treatment Action!
, from
The Center for AIDS
Getting Information About the FDA and Its Activities
(Summer 2002)
[Archived Article]
In
Research Initiative/
Treatment Action!
, from
The Center for AIDS
FDA Approves Once-Daily Efavirenz Formulation, Revised Labeling
(March 8, 2002)
[Archived Article]
In
AIDS Treatment News
, from
AIDS Treatment News
Report on FDA Antiviral Advisory Committee Discussion of Viread
(October 2001)
[Archived Article]
Including descriptions of Gilead's clinical trials for the drug.
In
GMHC Treatment Issues
, from
Gay Men's Health Crisis
Twinrix: Combined Hepatitis A and Hepatitis B Vaccine
(September 21, 2001)
[Archived Article]
From
U.S. Centers for Disease Control and Prevention
FDA Gives Salvage Therapy Testing a Push Forward
(March 23, 2001)
[Archived Article]
In
AIDS Treatment News
, from
AIDS Treatment News
FDA Issues Urgent Notice of Recalled Injectable Drugs
(January 25, 2001)
[Archived Article]
From
U.S. Food and Drug Administration
FDA Meeting on Approving Immune Therapies: Background and Comment
(October 20, 2000)
[Archived Article]
In
AIDS Treatment News
, from
AIDS Treatment News
E-Mail
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