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FDA Issues: Review & Approval of New Drugs & Other Regulatory Issues
- How HIV Drugs Get Approved (September 28, 2007)
To read PDF, click here
From AIDS InfoNet
- 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
- 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)
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)
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)
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
- Testimony on Accelerated Approval: September 1994 (November 2003)
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
- Treatment Activists Meet With the FDA (November 2003)
Highlights of a discussion on the development and approval of new HIV medications.
In GMHC Treatment Issues, from Gay Men's Health Crisis
- FDA Discusses Clinical Trial Designs for Microbicide Research (September 2003)
In GMHC Treatment Issues, from Gay Men's Health Crisis
- New Guidance on Clinical Trial Design in Developing Treatment for HIV Infection (November 1, 2002)
From U.S. Food and Drug Administration
- Washington: Judge Voids Rules on Pharmaceutical Tests (October 21, 2002)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
- Accelerated Approval: Where Are We Now? (Summer 2002)
In Research Initiative/Treatment Action!, from The Center for AIDS
- An Overview of the Drug Approval Process (Summer 2002)
In Research Initiative/Treatment Action!, from The Center for AIDS
- Getting Information About the FDA and Its Activities (Summer 2002)
In Research Initiative/Treatment Action!, from The Center for AIDS
- Counterfeit Drugs: Check Combivir, Serostim, Epogen (May 31, 2002)
In AIDS Treatment News, from AIDS Treatment News
- Boehringer Ingelheim Pharmaceuticals Withdraws AIDS Drug Application (March 25, 2002)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
- FDA Suspends Requirement That New Drugs Be Tested on Children (March 21, 2002)
In AIDS Action Weekly Update, from AIDS Action Council
- FDA Approves Once-Daily Efavirenz Formulation, Revised Labeling (March 8, 2002)
In AIDS Treatment News, from AIDS Treatment News
- Tenofovir: FDA Hearing on Important New Antiretroviral (October 19, 2001)
To read PDF, click here
In AIDS Treatment News, from AIDS Treatment News
- Report on FDA Antiviral Advisory Committee Discussion of Viread (October 2001)
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)
From U.S. Centers for Disease Control and Prevention
- FDA: New Email List on HIV/AIDS (July 27, 2001)
To read PDF, click here
In AIDS Treatment News, from AIDS Treatment News
- FDA Issues Advertising Warning to Pharmaceutical Companies (May 20, 2001)
In STEP Ezine, from Seattle Treatment Education Project
- Gilead Applies for FDA Approval of Nucleotide Analogue Tenofovir (May 20, 2001)
In STEP Ezine, from Seattle Treatment Education Project
- FDA Gives Salvage Therapy Testing a Push Forward (March 23, 2001)
In AIDS Treatment News, from AIDS Treatment News
- Monitoring Anti-HIV Medicines: What Is the FDA's Role? (Spring 2001)
In Bulletin of Experimental Treatments for AIDS, from San Francisco AIDS Foundation
- The Buzz (March/April 2001)
In Positively Aware, from Test Positive Aware Network
- Notice of FDA Advisory Committee Meeting on February 27, 2001 (February 2, 2001)
Valganciclovir hydrochloride tablets for treatment of cytomegalovirus (CMV) retinitis.
From U.S. Food and Drug Administration
- FDA Approves Videx EC and Trizivir (November 27, 2000)
In STEP Ezine, from Seattle Treatment Education Project
- FDA Meeting on Approving Immune Therapies: Background and Comment (October 20, 2000)
In AIDS Treatment News, from AIDS Treatment News
- FDA Public Meeting on Pharmacokinetics and Antiviral Response, July 25 near Washington D.C. (June 23, 2000)
Important policy meeting on development and testing of antiretroviral drugs.
In AIDS Treatment News, from AIDS Treatment News
- FDA Approves Drug for Meningitis in HIV Patients (Summer 2000)
In Women Alive Newsletter, from Women Alive
- Information about Gender and Race According to the FDA-Approved Labeling of Anti-HIV Drugs (Summer 2000)
To read PDF, click here
In CRIA Update, from AIDS Community Research Initiative of America
- HIV/AIDS Milestones 1995-1999 (October 7, 1999)
From U.S. Food and Drug Administration
- Life Savers (September/October 2008)
On the front lines at the FDA.
To read PDF, click here
In Positively Aware, from Test Positive Aware Network
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