FDA announces FY 2022 GDUFA science and research priorities

Regulatory NewsRegulatory News | 02 December 2021 |  By 

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.
 
The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.
 
The workshop was held in June 2021 on accelerating complex generic development. The feedback resulted in FDA’s revising several priority areas, said FDA in a four-page summary of its Generic Drug User Fee Amendments (GDUFA) science and research priority initiatives for FY 2022. (RELATED: FDA’s OGD hears ways to accelerate complex generic development, Regulatory Focus 24 June 2021)
 
Such feedback included prioritizing the global harmonization of bioequivalence (BE) standards. At the June workshop, Raja Velagapudi of Sandoz had put forward a proposal that FDA work with the International Council for Harmonization (ICH) on mutual use of bioequivalence data to ease the testing burden for approval of some generics.
 
Another research priority will be further work on such harmful impurities as nitrosamines. FDA plans to develop computational toxicology tools and conduct more investigation into nitrosamine formation and mitigation, as well as refine how human risks are assessed. “The scientific considerations 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,” according to the research initiatives document.
 
Orally inhaled products will be another research priority area, with focus on how to predict concentrations of inhaled products both within lung tissue and systemically. More research is needed into how to link computational fluid dynamics (CFD) models to mechanistic physiologically based pharmacokinetic (PBPK) models, according to FDA. CFD modeling can be used to examine how particle size distribution relates to regional lung deposition for orally inhaled products, a research area that should help develop new ways to demonstrate BE for these therapeutics.
 
The June workshop generated “specific feedback” regarding dissolution tests, which attendees said may not always provide sufficient evidence to support BE through physiologically based pharmacokinetic (PBPK) and pharmacokinetic/pharmacodynamic (PK/PD) models. FDA’s research priority in this regard will be to work on tools and methods for BE and therapeutic equivalence evaluation that bring together predictive dissolution and permeability test results. New approaches will also use machine learning techniques; FDA will also work “to support global harmonization of the most efficient BE recommendations.”
 
How artificial intelligence (AI) can be used in support of development and approval of generic drugs is another research area that will be prioritized, based on stakeholder feedback. Generics developers are already using AI and see more untapped potential in these computational techniques. FDA plans to look into “integrated technological solutions” that incorporate AI that the agency can use both in support of regulatory decision-making and in post-market surveillance of generic drug use.
 
FDA’s generics priority initiatives for FY 2022 follow the categories of complex generics that are mapped out in the GDUFA II commitment letter, addressing complex ingredients, formulations, or dosage forms; complex delivery routes; drug-device combination products; and, finally, tools and methods used to determine BE and therapeutic equivalence.
 
Fellowship opportunities and grant forecasts for FY 2022
 
FDA is offering a new fellowship for FY 2022, in collaboration with the Oak Ridge Institute for Science and Education (ORISE). The fellowship explores how different soft food properties may impact people with dysphagia, or difficulty in swallowing, a problem that affects about 15 million people in the US yearly. The study will look at “how different soft food properties may impact product quality, which can inform development of reliable in vitro assessments to characterize co-administration of drug products with soft food.” The application deadline is 31 January 2022.
 
Other fellowship opportunities include investigation into how FDA-funded scientific research can be used to support product-specific guidance development, and work on modeling dry powder inhalers (DPI) for drug delivery. The deadline for applying for these fellowships is 31 December 2021.
 
Questions may be sent to ORISE.FDA.CDER@orau.org. 
 
FDA is also forecasting availability of seven funding opportunities for which formal announcements have not yet been issued:
  • Using cutaneous pharmacokinetic-based approaches to establish bioequivalence for topically applied drug products 
  • Investigating in vitro based approaches to evaluate the bioequivalence of generic rectal and vaginal products 
  • Investigating the in vivo behavior and in vitro characteristics for gastro-retentive extended-release formulations to enhance the regulatory standard for such products 
  • Employing in vitro approaches to evaluate and compare the adhesion performance of transdermal and topical delivery systems (TDS) for drug patches 
  • Using PBPK modeling to assess BE of locally acting drugs in the gastrointestinal tract 
  • Investigating PBPK models for nose-to-brain drug delivery 
  • Developing advanced analytical methods for characterizing complex generics
 
GDUFA funding opportunities
 
GDUFA science and research priority initiatives
 

 

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