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Monday, July 15, 2019

Gilead gets Aug. 7 FDA panel date on PrEP combo

TIME: 8:30 a.m.
EVENT: Health and Human Services Department; Food and Drug Administration (F.R. Page 29521) holds a meeting of the Antimicrobial Drugs Advisory Committee to discuss supplemental new drug application 208215, supplement 12, DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV.
DATE: August 7, 2019
LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31 Conference Center, the Great Room, Room 1503, Silver Spring, Md.
CONTACT: Lauren Tesh Hotaki, 301-796-9001, AMDAC@fda.hhs.gov

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