Office of Generic Drugs FYs 2013 - 2017 Regulatory Science Research Report
- Complex Mixtures and Peptides
- Database and Knowledge Management
- Drug-Device Combinations
- Drug Products that Incorporate Nanotechnology
- Generic Drug Utilization and Substitution
- Locally-Acting Gastrointestinal Drugs
- Locally-Acting Orally Inhaled and Nasal Drug Products
- Long-Acting Injectables and Implants
- Modified Release Drug Products
- Ophthalmic Products
- Oral Abuse-deterrent Opioid Products
- Patient Substitution Studies
- Perceptions of Generic Drugs
- Pharmacokinetic/Pharmacodynamic Models and Pharmacometrics
- Physiologically-Based Absorption and Pharmacokinetic Models for Non-Oral Routes
- Predictive Dissolution and Physiological Models of Oral Absorption
- Topical Dermatological Drug Products
- Transdermal Drug Products
The Generic Drug User Fee Amendments of 2012 (GDUFA) regulatory science program and research activities support the development of new methodologies and tools. These methodologies and tools help establish drug equivalence standards and the development of, and access to, generic drug products.
The Office of Generic Drugs (OGD), through its Office of Research and Standards (ORS), built an extensive research portfolio to support development of new methodologies and tools to help establish equivalence standards. This report elaborates on the results of these efforts during GDUFA (GDUFA I).
Between 2013 and 2017, ORS awarded 36 research contracts and 69 grants for innovative research projects on generics. These contracts and grants resulted in significant accomplishments, from developing the scientific basis to support new and revised guidances for industry to refining methods for the evaluation of generic drug products.
Innovative approaches for evaluating equivalence and tools that support generic drug development are vital to making generic drugs available for complex drug products. Bioequivalence for such products frequently cannot be assessed by traditional pharmacokinetic methods and standards. Complex dosage forms are becoming more critical to patient care but generic versions are generally more difficult to develop due to lack of standards and tools that establish equivalency. The U.S. Food and Drug Administration regulatory guidance recommendations reflect current scientific knowledge on how to ensure development and manufacture of high quality generic drug products.
The GDUFA regulatory science program and research activities support our regulatory decision-making and development of general and product-specific guidances that provide industry with a roadmap to generic drug development. Under GDUFA I, FDA posted a total of 788 product-specific draft guidances, of which, 295 were for complex drug products that have streamlined product development as well as FDA review and approval of generic complex drug products.
The OGD research activities are divided into 18 topic areas. We have chosen several high-profile topic areas on which to provide an in-depth look of the progress made since the start of GDUFA. A comprehensive list of completed grants and contracts for all 18 areas can be found below.
The results from the first five years of the GDUFA regulatory science program illustrate the significant strides OGD made in addressing questions about therapeutic equivalence and the scientific evaluation of generic drug products. We want to thank our external and internal collaborators who have contributed greatly to this effort, and look forward to the future scientific achievements that will help enhance access to generic drugs for the American public.