FDA Touts Generic Drug Research in 2019
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.
In a section on data analytics, FDA’s Office of Research and Standards noted how it’s using machine learning to predict the time to the first submission of abbreviated new drug applications (ANDAs) referencing new chemical entities (NCEs) to inform ANDA workload and to prioritize research efforts.
In addition to ongoing research, FDA says it awarded 14 new research contracts and three grants in FY2019 and conducted more than 50 research projects using internal resources.
“Our GDUFA-funded research collaborations have resulted in significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products,” write Sally Choe, director of the Office of Generic Drugs, and Michael Kopcha, director of the Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research.
The two directors point out that in FY2019, FDA released 252 new and revised product-specific guidances for generic drugs and received 112 requests for pre-ANDA meetings for complex generic drugs.
Choe and Kopcha also credit GDUFA-funded research with aiding in the development of several first complex generic drugs, including the first generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) and the first generic for Zovirax (acyclovir) cream.
FDA