Generic Drug ANDA review process

Generic Drug ANDA review process - Letter Approval Withheld...

Info iconThis preview shows page 1. Sign up to view the full content.

View Full Document Right Arrow Icon
1 Generic Drug (ANDA) Review Process Bioequivalence Review Labeling Review Chemistry & Micro Review ANDA Acceptable & Complete Application Review N Chem/Micro OK? Labeling OK? Bioequivalence OK? PreApproval Inspection Results OK? Not Approvable
Background image of page 1
This is the end of the preview. Sign up to access the rest of the document.

Unformatted text preview: Letter Approval Withheld until Results Satisfactory Bio Deficiency Letter APPROVED ANDA N N N N Y Y Y Y Y Refuse to Receive Letter Source: FDAs Office of Generic Drugs Request for Plant Inspection...
View Full Document

This note was uploaded on 01/01/2012 for the course PHRM 7230 taught by Professor Tackett during the Spring '11 term at University of Georgia Athens.

Ask a homework question - tutors are online