FDA has released its revised outline of specific generic drug research priorities for FY 2022 (see here) based on feedback of stakeholders in a public meeting held on June 23, 2021 as well as written comments received on the 15 proposed research priorities announced at that meeting and the issues that FDA sought comments on in a March 24, 2021 FR notice (here).
The priorities are grouped into 4 major categories and each category has numerous sub-classifications. The major categories are outlined below:
A – Complex active ingredients, formulations, or dosage forms
B – Complex routes of delivery
C – Complex drug-device combination products
D – Tools and methodologies for BE and therapeutic equivalence evaluation
Oral inhalation products also present various pharmacokinetic and pharmacodynamic modeling challenges and the Agency, “based upon the comments has made a ‘FY 2022 science and research priority B1 has been revised to encompass improvements to not only PBPK models but also to CFD models, which can support alternative approaches by which to demonstrate bioequivalence (BE) for orally inhaled products.’”
FDA notes that one very important “scientific considerations (was) associated with harmful impurities such as nitrosamines are not specific to generic products but given the number of prescriptions filled by generic medications, this is a high priority for generic product manufacturers. This feedback was incorporated into revisions to the FY 2022 science and research priorities D2, D3, and D5” (see link above for details).
Other priorities associated with pharmacokinetic and or pharmacodynamic models to demonstrate bioequivalence of topical products is also discussed in D2. In addition, FDA revised D5 to include a priority for artificial intelligence (AI) in the development and evaluation of generic drugs.
Please review the entire document to obtain a full understanding of the FY 2022 generic drug research priorities.
