FDARA Marketing Status Report

FDARA Marketing Status Report

FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed into law. FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time. This enabled the FDA to continue to collect medical product user fees through fiscal year 2022.

FDARA also contained other requirements including the Marketing Status Report for NDA and ANDA (drug) holders. Under section 506I(c) of the FD&C Act, all NDA and ANDA holders are to review information published in FDA’s publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), and submit a one-time written report to FDA indicating that:

  1. the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale;
    or
  2. one or more of the NDA or ANDA holder’s drugs in the active section of the Orange Book have been withdrawn from sale or have never been available for sale.

Section 506I(c) of the FD&C Act requires that this one-time marketing status report be submitted to the FDA within 180 days of enactment of FDARA (i.e., by Wednesday, February 14, 2018). FDARA Marketing Status Reports must include several pieces of information and follow the format set out in Section 506I(c).

 

Contact our Washington DC or Research Triangle offices with any questions.

 

**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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