USA – FDA report details how agency supports generic-drug development

The US Food and Drug Administration (FDA) on Tuesday released a report detailing the scientific research carried out and funded by the agency in FY2019 to support the development of generic drugs under the Generic Drug User Fee Amendments (GDUFA II).
 
The 83-page report provides an overview of the research activities related to 13 research areas that fit within the four scientific priorities FDA set for FY2019, which include: complex active ingredients, formulations or dosage forms; complex routes of delivery; complex drug-device combination products; and tools and methodologies for bioequivalence and substitutability evaluation.
 
More specifically, the research addresses enhancing FDA’s assessment of abuse-deterrent formulations, generic dry powder inhalers, demonstrating bioequivalence and substitutability for generic drug-device combination products, and better handling the complexity of long-acting injectables and implants, among other areas…