Regulatory Roundup: FDA asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications

May 12, 2011
By Pharmaceutical Technology Editors
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FDA issued last week a final guidance for industry about over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication. Titled Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, the guidance describes how manufacturers can use dosage delivery devices and devices to help minimize the risk of unintentional overdose of OTC products. Read PharmTech’s blog about the guidance.

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications. According to a Federal Register notice, the Biologics Price Competition and Innovation Act of 2009, a provision of the Affordable Care Act, which creates an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with an FDA-licensed biological product, directs the agency to develop recommendations for a related user-fee program for fiscal years 2013 through 2017. The recommendations must be presented to Congress by January 15, 2012.

On May 5, FDA published the minutes of public and industry meetings held in February 2011, about the renewal of PDUFA.

FDA also issued a procedural notice about how CDER responds to requests for waivers of postmarketing safety reporting requirements for NDAs, ANDAs, and BLAs. The document explains how CDER reviews and responds to such requests.

USP and FDA are expanding their partnership for another three years to focus on developing USP written and physical reference standards for the quality, identity, purity, and strength of medicines. The new agreement, according to a USP announcement, furthers annual collaborative testing between USP and FDA laboratories of roughly 40 chemical reference standards, primarily for controlled substances. The agreement also promotes joint work to modernize tests and assays in USP’s standards and to further develop test methods for hand-held instruments that law enforcement inspectors can use to screen drugs in the field for adulteration, contamination, and authenticity, says the announcement.

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