FDA Issues Guidance for HIV Drug Development
On Monday, FDA issued new guidance for drugmakers that are developing treatments for HIV. The guidance includes recommendations for drugmakers producing therapeutic biologics and antiretroviral drugs to treat HIV. The guidance focuses particularly on drugs under development to treat "treatment-experienced patients" who have HIV and have not positively responded to other drugs.
- "FDA Issues Guidelines for HIV Drugs" (Devaney, The Hill, 11/2).