• AMEENPALLI BHAVANA
• DATLA NIKHILA
• DR. Y SARAH SUJITHA

NDA is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications. In addition to a chemical and pharmacologic description of the drug, an NDA must show the results of clinical trials conducted with respect to the indication for which a license is requested. The present thesis mainly discusses about the changes to approved nda and and a. On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to add section 506A. This section outlines the requirements for making and reporting manufacturing changes to approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), as well as the requirements for distributing a drug product made with these changes. In order to comply with section 506A, the FDA then revised its regulations regarding supplements and other changes to an approved application. If the holder of an NDA or ANDA is planning to make post-approval changes, they first need to specify the types of changes they’ll make which fall under one of three categories: major, moderate, or minor.

New drug application, Abbreviated new drug application, quality control, quality assurance, Regulatory Affairs.

"CHANGES TO AN APPROVED NDA AND ANDA", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.g188-g239, June-2024, Available :http://www.jetir.org/papers/JETIRTHE2126.pdf

"CHANGES TO AN APPROVED NDA AND ANDA", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppg188-g239, June-2024, Available at : http://www.jetir.org/papers/JETIRTHE2126.pdf