New Guidance Documents and GDUFA Public Hearing
1. Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 – Guidance for Industry
This draft guidance describes FDA's approach to implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) on or before March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this draft guidance describes FDA's interpretation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that have been or will be approved under the FD&C Act on or before March 23, 2020. This draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation the transition provisions of the BPCI Act.
2. Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations - Guidance for Industry
The guidance is intended to help sponsors determine the amounts and types of safety data to collect in late-stage premarket and postapproval clinical investigations based on what is already known about a drug's safety profile. Sponsors collect extensive safety data in clinical investigations of drug and biological products conducted to support marketing approval (premarket) and after approval (postapproval). FDA believes that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because certain aspects of a drug's safety profile will be sufficiently well-established and comprehensive data collection is not needed. This guidance finalizes the draft guidance issued in February 2012.
3. Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments
FDA is announcing a public hearing that will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2017 Regulatory Science Plan.