The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products: Surveillance Inspections […]

Inspections Classifications DatabaseThis database provides final inspection classifications for inspections related to currently marketed FDA-regulated products, including inspections of facilities that manufacture, process, pack, or hold […]

[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 […]