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Advancements in Bioequivalence & Bioavailability

Post-Approval Activities of ANDA: USFDA Regulation and Timeline

  • Open or Close Rumel Dey1* and Dona Roy Chowdhury2

    1Regulatory Affairs Department, SQUARE Pharmaceuticals Ltd, Bangladesh

    2Product Management Department, Eskayef Bangladesh Limited, Bangladesh

    *Corresponding author: Rumel Dey, Regulatory Affairs Department, SQUARE Pharmaceuticals Ltd., Dhaka Unit, Bangladesh

Submission: March 19, 2018; Published: June 08, 2018

DOI: 10.31031/ABB.2018.01.000513

ISSN 2640-9275
Volume1 Issue3


Post-approval activities are equally important throughout the lifecycle of a product. After got the approval of Abbreviated New Drug Application (ANDA) a product need to go through processes like submission of Final content of labeling, Electronic Drug Registration and Listing, Pharmacovigilance activities like ADER, FAR, PAS for any changes in the approved drug product for undisturbed and smooth commercial distribution of product.FDA have it own guidance and CFR for all these activities. Post-approval requirements for marketing applications, and requirements for the production of commercial products, are similar for products approved under either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA).

Keywords: Food and drug administration (FDA); Abbreviated new drug application (ANDA); Adverse drug experience reports (ADE); Field alert reports (FARs); Prior-approval supplement (PAS); Code of federal regulation (CFR); National drug code (NDC); New drug application (NDA); Changes being effected (CBE)

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