Summary Company Announcement Date: April 18, 2025 FDA Publish Date: April 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product may contain an […]

Date: May 15, 2025 Time: 9:00 a.m. – 4:30 p.m. ET Organized By: Contributor: Contributor After much consideration, we are postponing the Interested Parties Meeting: Implementation […]

Summary Company Announcement Date: October 31, 2023 FDA Publish Date: November 01, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Insanitary manufacturing conditions Company […]

FDA has reevaluated the rationale document entitled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute (CLSI) to susceptibility […]

The FDA Public Engagement Staff is responsible for managing the agency’s Patient Listening Session program. This page contains a list of all the Patient Listening Sessions that […]

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER March 26, 2024 RE: 701480 Dear Andy […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Robert P. Nickell Recipient Title CEO Nubratori, Inc. dba Nubratori […]

Delivery Method: VIA UPS Reference #: 320-25-62 Product: Drugs Recipient: Recipient Name Ms. Lina M. Kennedy Recipient Title President and CEO PMS4PMS, LLC 4255 Research PkwyClarence, […]

Español [4/14/2025] FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. […]