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ShareFDA 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
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