[5/16/2024] FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated labeling includes a new warning that using […]

Delivery Method: Via Electronic Mail Return Confirmation Requested Product: Drugs Recipient: Recipient Name Brian Tyler Recipient Title CEO McKesson Corporation Headquarters 6555 State Hwy 161Irving, TX […]

FDA has reviewed data supporting ceftazidime breakpoints against Stenotrophomonas maltophilia. The review was conducted after the Clinical and Laboratory Standards Institute (CLSI) removed the breakpoints from […]

Sun protection factor (SPF) The SPF value indicates the level of sunburn protection provided by the sunscreen product. All sunscreens must be tested to measure the […]

Spotlight Events & Announcements Get Started with Your Submission The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program accepts submissions for qualification of […]

The FY 2021 GDUFA Science and Research report provides detailed results for 13 areas of focus, each including a summary of research activities, research highlights, comprehensive […]

The FY 2022 GDUFA science and research report describes active research projects and outcomes organized in 13 scientific areas. In each area, we summarize the relevant […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate Commissioner for Women’s Health and Director of the […]

Introduction This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic […]