Post-Approval Changes to NDA and ANDA ppt pdf

Holders who intend to make post-approval changes to NDA and ANDA should follow in accordance with section 506A of the Federal Food, Drug, and  Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength,  quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.

Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval (for an existing licensed approved drug). The ANDA is submitted to the office of Generic drugs, US. After a review of the documents, USFDA gives approval as generic drugs.

After approval, an applicant may manufacture and market the generic drug product to the US market. A generic drug product is one that is similar to branded drug product in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.

New Drug Application (NDA), Investigational New Drug (IND), Abbreviated New Drug Application (ANDA)

The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.

The investigational new drug (IND) application is the result of a successful preclinical development program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials).

An Abbreviated New Drug Application (ANDA) contains data submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, for review and ultimate approval of a generic drug product.

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