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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
- 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
Antiretroviral Therapy
Antiretroviral Therapy
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