FDA has completed their review of the rationale document submitted by the Clinical Laboratory and Standards Institute (CLSI) to STIC Docket# FDA-2017-N-5925-023, entitled, “Cefazolin Breakpoints for […]

Cefazolin is a first-generation cephalosporin for parenteral administration that is indicated for the treatment of a number of bacterial infections including urinary tract infections. 1 In February […]

Summary FDA has reevaluated the rationale document submitted by the Clinical and Laboratory Standards Institute (CLSI) to susceptibility test interpretive criteria docket #FDA-2017-N-5925-017, entitled, “Azithromycin Breakpoint […]

CDER reviews drug applications to ensure the products are safe and effective.  When we review applications, we always evaluate the appropriate drug dose that should be […]

On This Page Date: October 7 – 8, 2025 Day1: Tue, Oct 07 9:00 a.m. – 04:00 p.m. ET Day2: Wed, Oct 08 9:00 a.m. – […]

Summary Company Announcement Date: August 19, 2025 FDA Publish Date: August 19, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence […]

Delivery Method: VIA UPS Reference #: 320-25-99 Product: Drugs Recipient: Recipient Name Ms. Rosy Atwal Recipient Title Founder and CEO Everlaan Organics, Inc. dba Maple Organics […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-100 Product: Drugs Recipient: Recipient Name Mr. Alex Li Recipient Title CEO Anhui Hanbon Daily Chemical Co., Ltd. No.55 […]