Simpler Grants.gov #FOR-FD-24-006

FDA Research Grant for Tools Assessing Alcohol Dose Dumping in Modified Release Oral Drug Products

The Food and Drug Administration (FDA) is seeking research partners through a cooperative agreement grant to advance tools for evaluating alcohol dose dumping (ADD) in modified release (MR) oral drug products. - Government Buyer: - Food and Drug Administration (FDA) - OEMs and Vendors: - No specific OEMs or vendors are named, as this is a research grant opportunity - Products/Services Requested: - Research services to develop tools that: - Facilitate the development of MR generic drug products with low potential for alcohol dose dumping - Support regulatory decision-making for MR oral drug products containing high-risk drugs - Address differences in ADD assessment guidelines between the FDA and the European Medicines Agency - Improve prediction of in vivo behavior from in vitro tests - Unique or Notable Requirements: - Focus on regulatory science and evidence generation for ADD in MR oral drug products - Open to a wide range of nonprofit, educational, business, and government entities - Award amount is set at $250,000 - Place of Performance: - Food and Drug Administration (federal office)

Description

This funding opportunity from the Food and Drug Administration aims to support research to develop tools that facilitate the development of modified release (MR) generic drug products with a low potential for alcohol dose dumping (ADD). The research will also support regulatory decision making and provide evidence to develop specific recommendations for demonstrating low or comparative potential of ADD in MR oral drug products containing high risk drugs. The scope includes addressing differences in ADD assessment guidelines between regulatory agencies and improving the prediction of in vivo behavior from in vitro tests.

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