Drugs

GDUFA Science and Research Priority Initiatives

FDA has released 15 Fiscal Year 2022 GDUFA science and research priority initiatives. The agency says the initiatives are organized according to the categories of complex generic drug products described in the GDUFA 2 commitment letter, followed by a category addressing tools and methodologies for evaluating bioequivalence and therapeutic equivalence more generally. “These initiatives are based on the need to develop efficient and modern generic drug research, development, and review tools,” the notice says.

The four categories (with the number of initiatives in each) are:

complex active ingredients, formulations, or dosage forms (5);
complex routes of delivery (3);
complex drug-device combination products (2); and
tools and methodologies for bioequivalence and therapeutic equivalence evaluation (5).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome