FDA Issues: Review & Approval of New Drugs & Other Regulatory Issues
- Pfizer HIV Drug Seems Safe for New Use -- FDA Staff (October 7, 2009)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
- FDA OKs Second HIV Donor Screening Test (September 23, 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
- How HIV Drugs Get Approved (August 9, 2009)
To read PDF, click here
From AIDS InfoNet
- 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
- 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
- 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
- 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
- FDA Discusses Clinical Trial Designs for Microbicide Research (September 2003)
[Archived Article]
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)
[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
- Accelerated Approval: Where Are We Now? (Summer 2002)
[Archived Article]
In Research Initiative/Treatment Action!, from The Center for AIDS
- An Overview of the Drug Approval Process (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
- Counterfeit Drugs: Check Combivir, Serostim, Epogen (May 31, 2002)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Boehringer Ingelheim Pharmaceuticals Withdraws AIDS Drug Application (March 25, 2002)
[Archived Article]
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)
[Archived Article]
In AIDS Action Weekly Update, from AIDS Action Council
- FDA Approves Once-Daily Efavirenz Formulation, Revised Labeling (March 8, 2002)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Tenofovir: FDA Hearing on Important New Antiretroviral (October 19, 2001)
[Archived Article]
To read PDF, click here
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: New Email List on HIV/AIDS (July 27, 2001)
[Archived Article]
To read PDF, click here
In AIDS Treatment News, from AIDS Treatment News
- FDA Issues Advertising Warning to Pharmaceutical Companies (May 20, 2001)
[Archived Article]
In STEP Ezine, from Seattle Treatment Education Project
- Gilead Applies for FDA Approval of Nucleotide Analogue Tenofovir (May 20, 2001)
[Archived Article]
In STEP Ezine, from Seattle Treatment Education Project
- FDA Gives Salvage Therapy Testing a Push Forward (March 23, 2001)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Monitoring Anti-HIV Medicines: What Is the FDA's Role? (Spring 2001)
[Archived Article]
In Bulletin of Experimental Treatments for AIDS, from San Francisco AIDS Foundation
- The Buzz (March/April 2001)
[Archived Article]
In Positively Aware, from Test Positive Aware Network
- Notice of FDA Advisory Committee Meeting on February 27, 2001 (February 2, 2001)
[Archived Article]
Valganciclovir hydrochloride tablets for treatment of cytomegalovirus (CMV) retinitis.
From U.S. Food and Drug Administration
- FDA Issues Urgent Notice of Recalled Injectable Drugs (January 25, 2001)
[Archived Article]
From U.S. Food and Drug Administration
- FDA Approves Videx EC and Trizivir (November 27, 2000)
[Archived Article]
In STEP Ezine, from Seattle Treatment Education Project
- FDA Meeting on Approving Immune Therapies: Background and Comment (October 20, 2000)
[Archived Article]
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)
[Archived Article]
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)
[Archived Article]
In Women Alive Newsletter, from Women Alive
- Information about Gender and Race According to the FDA-Approved Labeling of Anti-HIV Drugs (Summer 2000)
[Archived Article]
To read PDF, click here
In CRIA Update, from AIDS Community Research Initiative of America
- Dietary Supplement Regulation: FDA Public Hearing April 4, Written Comments Due May 4 (March 17, 2000)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- FDA Drug-Approval Background: New Web Pages (March 17, 2000)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Drug Approval Application Process (March 14, 2000)
[Archived Article]
A new Food and Drug Administration (FDA) site explaining the drug development process.
- Gilead vs. FDA (Winter 1999/2000)
[Archived Article]
The FDA eviscerates a new drug application.
In GMHC Treatment Issues, from Gay Men's Health Crisis
- FDA OKs New Videx Formulation (December 1999)
[Archived Article]
In Positive Living, from AIDS Project Los Angeles
- HIV/AIDS Milestones 1995-1999 (October 7, 1999)
[Archived Article]
From U.S. Food and Drug Administration
- Threat to Compounding of Topical Testosterone, Other Pharmaceuticals: FDA Proposes Limit on Interstate Shipment (June 4, 1999)
[Archived Article]
From AIDS Treatment News
- FDA Reform Signed Into Law (December 5, 1997)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- The FDA Decides the Fate of Two Drugs for AIDS-Related Malignancies (November 1997)
[Archived Article]
In TAGline, from Treatment Action Group
- FDA Reform Sails Through Congress (October 1997)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- Republicans and Pharmaceutical Industry Target the FDA (October 1997)
[Archived Article]
In TAGline, from Treatment Action Group
- Senate Passage of FDA "Reform" Bill Threatens Safety of People With HIV/AIDS (September 24, 1997)
[Archived Article]
From AIDS Action Council
- Senate Committee Passes FDA Bill That AIDS Action Calls a Threat to Drug Safety, American Consumers (June 20, 1997)
[Archived Article]
From AIDS Action Council
- AIDS Action Alert: Call Your Senator About FDA "Reform"; Don't Let Congress Put the Public Health at Risk (June 12, 1997)
[Archived Article]
From AIDS Action Council
- AIDSfax: Congressional, Pharmaceutical Industry Tampering with FDA Threatens Drug and Medical Device Safety, Endangers Consumers (June 5, 1997)
[Archived Article]
From AIDS Action Council
- FDA Advisory Committee Deadlocks on Delavirdine (December 6, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Delavirdine Data at the FDA (December 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- Delavirdine Dilemma at the FDA (December 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- FDA Reform in Congress: FDA's Concerns (April 19, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- FDA Reform in Congress: Interview With Peter Barton Hutt (April 19, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- AZT, ddI, and ddC Combinations at FDA Advisory Hearing (April 5, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Human Growth Hormone Not Recommended for Approval on Narrow Advisory Panel Vote (March 15, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Growth Hormone Cut Down at the Pass (March 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- New from the Food and Drug Administration (FDA) (March 1996)
[Archived Article]
In Moore News for Care Providers, from Johns Hopkins AIDS Service
- Three Days That Shook the World (March 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- Principles of FDA Reform (February 13, 1996)
[Archived Article]
From AIDS Action Council
- The Growing Debate Over FDA Reform (January 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
- FDA Reform: New Senate Bill (November 17, 1995)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- Community Envoy to Food and Drug Panel Urges Caution in Approving New Anti-HIV Therapueutics and in Providing Early Access (October, 1995)
[Archived Article]
An excerpt from Peter Staley's remarks to the FDA's advisory committee regarding its Accelerated Approval program and viral load tests.
In TAGline, from Treatment Action Group
- FDA Reform: Activists' Proposals (August 4, 1995)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
- FDA Accelerated Approval Program Public Hearing (October 1994)
[Archived Article]
In TAGline, from Treatment Action Group
- News From the FDA (August 1994)
[Archived Article]
In TAGline, from Treatment Action Group
- 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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