HIV Drugmakers Get Updated FDA Tips to Boost Global Response

Makers of HIV drugs for global distribution may add manufacturing sites or make other application changes after receiving tentative approval from the FDA, according to revised draft guidance published Wednesday.

The proposed recommendations from the Food and Drug Administration include updates to 2006 final guidance on the development and review of antiretroviral, or ARV, drug products for the treatment or prevention of HIV as part of the President’s Emergency Plan for AIDS Relief (PEPFAR). The guidance intends to help boost this global response to HIV infections, which as of 2022 affect an estimated 39 million people across the world, according ...