• January 25, 2005. US Food and Drug Administration. FDA Grants Tentative Approval to Generic AIDS Drug Regimen for Potential Purchase Under the President's Emergency Plan for AIDS Relief.
• January 25, 2005. Aspen Pharmacare. World first from Aspen Pharmacare.
• January 26, 2005. Health GAP press release. Aspen's FDA Approval Weak Evidence of the Effectiveness of the FDA Expedited Approval Process.
• January 25, 2005. Brook Baker for Health GAP. Aspen's FDA Approval Weak Evidence of the Effectiveness of the FDA Fast-Track Process.
• January 25, 2005. AIDS Health Foundation. US' Largest AIDS Group Urges PEPFAR Officials to Quickly Incorporate Less Costly ARVs Regimens From Aspen Pharmacare Into Ambitious Global AIDS Treatment Efforts.

• January 26, 2005. Kaiser News Network. Politics and Policy | FDA Approves Generic Antiretroviral Drug Combination, Allowing PEPFAR To Purchase Drugs for Use in Developing Countries.
• January 26, 2005. Donald McNiel for the New York Times. A Path to Cheaper AIDS Drugs for Poor Nations.
• January 26, 2005. Business Day. Aspen Gets U.S. Nod to Supply $15bn Aids Drive.
• January 26, 2005. BBC. Aids group welcomes drug approval.
• January 25, 2005. Business Day. Aspen gets FDA approval for use of ARVs.
• January 25, 2005. James Macharia for the Independent. SA drug company gets US approval for ARVs.
• January 25, 2005. iafrica.com. Aspen Spiks with FDA Approval.

• July 2, 2004. Reuters. Cheap AIDS pill as good as pricey brands - Drug should be used in developing countries, experts say
• July 2, 2004. Marilyn Chase for the Wall Street Journal. Generic AIDS Pill Gets Acceptance.
• July 2, 2004. Donald McNeil for the New York Times. Study Finds Generic AIDS Drug Effective.
• July 2, 2004. BBC. Cheaper HIV drugs 'just as good.'
• July 2, 2004. Chidanand Rajghatta for the Times of India. Indian AIDS drugs pass test.
• July 2, 2004. Catherine Brahic for Sci.Dev.net. Generic HIV/AIDS therapy is 'safe and effective.'

• July 8, 2004. Rep. Henry Waxman. Letter to DHHS Secretary Thompson on Fixed Dose Combination ARVs.
• May 18, 2004. Randall Tobias, U.S. Global AIDS Coordinator. Excerpt from prepared testimony at the Senate Appropriations Committee.
• May 17, 2004. DHHS draft guidance document available for comment. Guidance for Industry Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV. Also see the Federal Register Notice for submission of comments.
• May 17, 2004. US Department of State. U.S. Health Officials Discuss New Review Process for HIV/AIDS Drugs - FDA will speed review of combination drug therapies, generics.
• May 16, 2004. DHHS press release. HHS Proposes Rapid Process For Review of Fixed Dose Combination and Co-Packaged Products
• May 16, 2004. DHHS fact sheet on the policy. FDA Review of HIV Drugs.
• May 11, 2004. Letter from Rep. Waxman to President Bush on Use of FDCs.

• May 18, 2004. World Health Organization. Statement of the World Health Organization on United States Proposal for Rapid Review of Fixed Dose Combinations.
• May 18, 2004. Medecins Sans Frontieres. MSF statement on US government announcement of new procedure for reviewing the safety and efficacy of fixed-dose combinations and co-blisters of antiretrovirals.
• May 18, 2004. Global AIDS Alliance. New Policy on AIDS Drugs a Slap to WHO and European Allies.
• May 17, 2004. Health GAP. New F.D.A. Program to Approve AIDS Drugs for Poor Countries: Cover for Shutting Out Generics in U.S. Bilateral Program?
• May 17, 2004. Global Fund to Fight AIDS, TB and Malaria. The Global Fund Welcomes Moves to Facilitate Wider Use of Fixed-Dose Combination Drugs Against AIDS.

• May 18, 2004. Donald McNeil for the New York Times. Views Mixed on U.S. Shift on Drugs for AIDS.
• May 18, 2004 New York Times editorial. Progress on Pills.
• May 18, 2004. Jim Lobe for OneWorld.net. Africa, AIDS Groups Blast Bush Plan.
• May 17, 2004. Maggie Fox for Reuters. U.S. to change AIDS drug policy.
• May 17, 2004. Kaiser News Network. Politics and Policy | New Fast-Track Review Program Will Approve AIDS Drugs for PEPFAR; Drug Companies Collaborating To Produce FDCs.
• May 17, 2004 Sarah Lueck for the Wall Street Journal. U.S. Says 3-in-1 AIDS Drugs For Poor Nations Need Review.
• May 17, 2004. Lawrence Altman for the New York Times. U.S. Speeding Up Approval Steps for AIDS Drugs.
• May 17, 2004. Geoff Dyer for the Financial Times. US to approve Aids drugs faster.
• May 15, 2004. Lauran Neergaard for the Associated Press. FDA to Vow Fast Approval of AIDS Drugs.

• July 2, 2004. A fixed-dose combination of generic antiretroviral drugs is validated in a clinical trial.
• May 22, 2004. Patents may hamper the development of new fixed dose combinations.
• April 7, 2004. Dr. Lulu Oguda. Testimony for the Senate Foreign Relations Committee Subcommittee on African Affairs hearing on “Fighting HIV/AIDS in Africa: A Progress Report.”
• February 16, 2004. Two Pills a Day Saving Lives: Fixed-Dose Combinations of Antiretroviral Drugs.
• October 23, 2003. AIDS Drugs Now Available for 36 US Cents a Day Under Clinton Foundation Deal.
• September 20, 2003. ARV Simplification for High-Prevalence Countries.
• Op-eds/Letters to the Editor by MSF Staff.
  • April 7, 2004. Omar Saleban (Field Director in Kenya). Letter to the Editor of the San Fransisco Chronicle.
  • April 2, 2004. Ellen t'Hoen. Director of MSF Campaign for Access to Essential Medicines. Letter to the Editor of the International Herald Tribune.

• March 1, 2004. U.S. Uses Drug Quality Smokescreen In PEPFAR Procurement Policies to Subsidize Big Pharma and to Prevent Procurement of Lower Cost Generics.
• December 18, 2003. U.S.'s Misguided and Bad-Faith Attack on the WHO's 3-by-5 Plan

  ...There are two central and interrelated benefits that arise from the use of FDCs in the administration of Highly Active Antiretroviral Therapy (HAART) in developing countries. The first is a lower overall pill count that predictably increases adherence to treatment regimes. The second is that FDCs have been shown to increase compliance because patients can take all their required medicines on a regular and fixed schedule rather than having to cope with a more complicated schedule of multiple pills on differing time schedules. The impact of reduced pill count and of simplified dosing schedules is to decrease the incidence of resistance of the AIDS virus to ARV treatment.

• May 5, 2004. Op-ed by Mardge Cohen and Gordon Schiff of the Health Action AIDS campaign of Physicians for Human Rights. Ban on generic AIDS drugs will prove to be fatal mistake.
• April 21, 2004. Abner Mason for the AIDS Responsibility Proejct. Statement on the Unanimous Passage by the Presidential Advisory Council on HIV/AIDS of a Resolution Ensuring Only Drugs Proven to be Safe and Effective Are Bought for Africans.
• April 15, 2004. Joint press release from the HIV Medicine Association and the Infectious Diseases Society of America. President's Plan Would Limit Access To Effective, Low-Cost Generic AIDS Drugs in Developing Countries.
• April 8, 2004. Thompson Ayodele for the Insitute for Policy Analysis. AIDS Drugs: No Compromise on Safety and Quality.

WHO encourages the use of fixed-dose combinations when formulations of assured quality and proven bioequivalence are available and offer operational advantages... WHO operates a voluntary prequalification system, in which, as of 1 December 2003, three manufacturers prequalified ZDV/3TC combinations, two prequalified d4T/3TC/NVP combinations, and one prequalified ZDV/3TC/ABC. The list of WHO-prequalified manufacturers is continuously updated and is available at: http://www.who.int/medicines