Latest FDA News

Compounding: Inspections, Recalls, and other Actions

Human drug compounding; FDA inspections; compounding recalls

Facility Readiness: Goal Date Decisions Under GDUFA

This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h.

Newly Added Guidance Documents

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

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

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.

FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute

FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute

All FDA News

Medical Disclaimer

Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum? provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. The information within all other sections is proprietary to Everyday Health.?