On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular […]

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 […]