PharmD Info

[Admin]

This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.

Guideline includes following details:
- PATENT AND EXCLUSIVITY DEFICIENCIES
- LABELING DEFICIENCIES
- PRODUCT QUALITY DEFICIENCIES
- BIOEQUIVALENCE DEFICIENCIES

To download the guidelines follow the below link.