FDA Roundup: March 4, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Other Meeting Options Related to Human Drugs

Learn more about established meeting request processes for different types of meeting options related to human drugs.

Personal Importation

Personal Importation

Importing Human Drugs

FDA importing requirements for human drug products,

WK Kellogg earmarks $200M for supply chain updates in 2025

The funds will support a multiyear initiative that has already led to improved productivity and reduced waste, according to company…

Nova-Tech, Inc. Issues Voluntary Nationwide Recall of Lactated Ringers 5 L Injectable Solution for Veterinary Use Due to Potential Presence of Fiber-like Particles

Grand Island, Nebraska, Nova-Tech, Inc. is voluntarily recalling one (1) lot of Lactated Ringers Injection for Animal Use Only to…

Navigating Controlled Correspondences to Support Generic Drug Development – 02/27/2025

Navigating Controlled Correspondences to Support Generic Drug Development

Untitled Letters

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled…

TKTX Numb Store – 697051 – 02/25/2025

Drug Products/Adulterated/Misbranded

TKTX USA – 698435 – 02/25/2025

Unapproved New Drugs/Misbranded