FDA issues guidances for long-acting PrEP, pediatric HIV drug development

FDA released final versions of two guidances Tuesday aimed at developing drugs for pediatric HIV patients and for pre-exposure prophylaxis (PrEP), which HHS Secretary Alex Azar said was in line with the Trump administration's HIV initiative in remarks at the National HIV Prevention Conference.

Last month President Donald Trump unveiled an initiative to slash the rate of HIV transmission. At the conference, Azar called PrEP a "key tool" to protect against HIV infection, one of the initiative's strategies (see "Trump Announces HIV, Children's Cancer Initiatives")...