New Drug Application (NDA) Process (CBER)
Drug Master Files for CBER-Regulated Products
A Drug Master File (DMF) is a voluntary submission of confidential information to FDA about facilities, manufacturing, processing, packaging, and storing of one or more human drug products.
Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications 7/10/2008 Questions and Answers Regarding the Complete Response Letter Rule Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions 12/12/2007 Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction 12/26/2007 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requiremetsof ClinicalTrials.gov (PDF)(PDF - 2.6MB)
FDA Form 3674
U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlines