The US Food and Drug AdministrationThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA). also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA[Therapeutic Goods Administration] The federal government body that approves drugs and treatments before they can be prescribed.). and the European Medicines Agency have strengthened their warnings to doctors and patients about the potential of the HIV protease inhibitorA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate. saquinavir (Invirase) to cause disturbances in electrical activity in the heart leading to abnormal heart rhythm when the drug is combined with a boosting dose of ritonavir (Norvir). read more »