Author: Barbara W. Unger

New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for

Read More »

Recent Generic Drug Guidance

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief October has so far seen a flurry of guidance publications focused on generic drugs. 

Read More »

Can’t find what you are looking for? Contact us.