Updated August 21, 2023 FDA is evaluating bulk drug substances that were nominated for inclusion on the 503B bulks list, proceeding case by case, under the […]
Report a counterfeit drug to FDA Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain […]
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 […]
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