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January 19, 2023

Electronic Drug Registration and Listing Using CDER Direct – 10/22/2019

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 […]
January 18, 2023

CTX Lifesciences Private Ltd. – 577416 – 01/11/2023

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 […]
January 17, 2023

CDER SBIA YouTube Learning Library

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 […]
January 17, 2023

FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales

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) […]
January 17, 2023

FDA Rationale for Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.

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,” […]
January 17, 2023

Optum Infusion Services 308 LLC – 647842 – 12/13/2022

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 […]
January 17, 2023

HIS Enterprise Inc dba Adam’s Secret USA, LLC – 646494 – 01/10/2023

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 […]
January 17, 2023

Clinical Investigator Administrative Actions – Disqualification

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 […]
January 13, 2023

Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

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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