On This Page Date: October 22, 2019 Time: 9:00 AM – 4:00 PM ET Location: Event Location The Hotelat the University of Maryland 7777 Baltimore Ave.College […]
Product: Drugs Recipient: Recipient Name Mr. Kanak J. Jariwala Recipient Title Managing Director CTX Lifesciences Private Ltd. Block No. 251-252, Sachin Magdalla RoadGIDCSachin, Surat 394230GujaratIndia Issuing […]
FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library – now hundreds of our recordings are readily accessible. Bookmark and […]
FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Enterobacterales” (MR14, February 2022), submitted by the Clinical and Laboratory Standards Institute (CLSI) […]
FDA has completed their review of the rationale document titled, “Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp. – CLSI Rationale Document MR01-Ed2, April 2020,” […]
Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name William J. Kottmer, PharmD Recipient Title General Manager Optum Infusion Services 308 LLC 2555 West […]
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER January 10, 2023 PO Box 281Palisades […]
Docket Number: FDA-2010-D-0265 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical […]
Submit Comments by 03/14/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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