FDA Issues: Review & Approval of New Drugs & Other Regulatory Issues

See also: New HIV Medications

Mylan Receives U.S. Approval for HIV/AIDS Treatment (September 22, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
FDA Approval of Generic ARVs (July/August 2011)
To read PDF, click here.
In HIV Treatment Bulletin, from HIV i-Base
FDA Approve Telaprevir (Incivek) to Treat Hepatitis C (July/August 2011)
To read PDF, click here.
In HIV Treatment Bulletin, from HIV i-Base
FDA Approve Boceprevir (Victrelis) for HCV (July/August 2011)
To read PDF, click here.
In HIV Treatment Bulletin, from HIV i-Base
FDA Approve New NNRTI-Based Fixed-Dose Combination of Rilpivirine/Tenofovir/FTC (Complera) in the U.S. (July/August 2011)
To read PDF, click here.
In HIV Treatment Bulletin, from HIV i-Base
FDA Approve New NNRTI Rilpivirine (Edurant) in the U.S. (July/August 2011)
To read PDF, click here.
In HIV Treatment Bulletin, from HIV i-Base
How HIV Drugs Get Approved (August 4, 2011)
To read PDF, click here.
From AIDS InfoNet
FDA and FTC Act to Remove Fraudulent HIV and STD Products From the Market (June 9, 2011)
From AIDS.gov
FDA Cracks Down on Sale of Bogus STD Cures (May 4, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
FDA, FTC Act to Remove Fraudulent STD Products From the Market (May 3, 2011)
From U.S. Food and Drug Administration
FDA Panel Backs Experimental Merck Hepatitis Drug (April 28, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
FDA Says Merck Drug Successfully Fights Hepatitis (April 26, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
U.S. Backs Roche Cervical Cancer Test (April 26, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
FDA Approves Egrifta for Treatment of Lipodystrophy in People With HIV (November 10, 2010)
From U.S. Food and Drug Administration
FDA Drafts New Rules for Testing, Approving Drug Cocktails; Public-Private Partnership for TB Treatment Development Launched (March 18, 2010)
In Kaiser Daily Global Health Policy Report, from Henry J. Kaiser Family Foundation
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
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
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
Drug Approval: Moving Drugs From the Laboratory to the Pharmacy (September 2006)
From The Well Project
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
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
FDA Approves New HIV and HCV Tests (Summer/Autumn 2002)
[Archived Article]
In Bulletin of Experimental Treatments for AIDS, from San Francisco AIDS Foundation
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
Accelerated Approval: Where Are We Now? (Summer 2002)
[Archived Article]
In Research Initiative/Treatment Action!, from The Center for AIDS
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
FDA Drug-Approval Background: New Web Pages (March 17, 2000)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
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
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
Republicans and Pharmaceutical Industry Target the FDA (October 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
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 Dilemma at the FDA (December 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
Delavirdine Data at the FDA (December 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
FDA Reform in Congress: Interview With Peter Barton Hutt (April 19, 1996)
[Archived Article]
In AIDS Treatment News, from AIDS Treatment News
FDA Reform in Congress: FDA's Concerns (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
New from the Food and Drug Administration (FDA) (March 1996)
[Archived Article]
In Moore News for Care Providers, from Johns Hopkins AIDS Service
Growth Hormone Cut Down at the Pass (March 1996)
[Archived Article]
In GMHC Treatment Issues, from Gay Men's Health Crisis
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