March 19, 2019
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis. The purpose of this guidance is to provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products (including small molecules and monoclonal antibodies). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on June 13, 2018. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate along with a few editorial changes.
https://www.fda.gov/downloads/
https://www.fda.gov/downloads/
Kimberly Struble
Division of Antiviral Products
Division of Antiviral Products
Food and Drug Administration
Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration
Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration
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