Abstract

POST APPROVAL CHANGES IN GENERIC DRUG PRODUCTS AND MARKETED DRUG PRODUCTS ACCORDING TO USFDA: A REVIEW

Vaidehi Daruvuri*, G. Ramakrishna and M. V. Nagabhushanam

Abstract

The post approval changes are the changes made to generic and marketed drug products that have received an approval and to provide the data to support a change which would be considered suitable and sufficient to allow a determination of the impact of the change on the quality of the approved products as it relates to safety, efficacy and effective use of the products. After the approval of NDA or ANDA, the applicant may make post approval changes, provided the changes are reported to the FDA under the appropriate categories. Section 506 A of the Federal Food, Drugs and Cosmetics act and 21 CFR 314.70 provide for three reporting categories of the post approval changes namely: major change, moderate change and minor change. There are many reasons for making changes to pharmaceutical products after the original regulatory approval is obtained. Company change control procedures should detail how changes are evaluated and implemented as well as how the change impacts stability and what data will be needed to support the change. The regulatory group will determine the strategy for submission based on a review of the technical assessment of the change and the appropriate regulatory guidance.

Keywords: NDA, ANDA, Post Approval Changes, Regulatory Approval, Generic Drugs, Marketed Drugs.