US FDA

August Egg Company of Hilmar, CA is recalling 1,700,000 dozen brown cage free and brown certified organic eggs, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other

Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level.

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

GDUFA User Fee Lists

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

This page contains the meeting materials for the Cardiovascular & Renal Drugs Advisory Committee meetings for 2023.

This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.

Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.