Slide 1 Slide 2 Arthur Fabian, PhD February 7, 2007 FDA Public Meeting Rockville MD Slide 3 SST Business Model Represent numerous API & Intermediate Manufacturers worldwide.…

PowerPoint Presentation Drug Master File Drug Master File Drug Master File Drug Master File Drug Master File Drug Master File & SUBMISSIONS Definition A drug master file…

DMFs Under GDUFA: DMF Basics Small Business Webinar 2013 DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. FDA DMF Expert FDA Small Business Office Webinar…

DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Drug Master Files • A Drug Master File (DMF) is a submission of proprietary information to…

DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Drug Master Files • A Drug Master File (DMF) is a submission of information to the FDA to…