Overview:
FDA prepares a yearly list of regulatory science priority initiatives for generic drugs as part of a commitment in the Generic Drug User Fee Amendments of 2017 (GDUFA II). These priority initiatives are chosen based on input from FDA, industry and other stakeholders.
The annual report reflects the GDUFA-funded research activities carried out by FDA and external grantees. Research activities follow the FY2019 GDUFA Regulatory Science Priority Initiatives, which fall broadly into the following categories:
- Complex active ingredients, formulations, or dosage forms
- Complex routes of delivery
- Complex drug-device combination products
- Tools and methodologies for bio-equivalence and sustainability evaluation
GDUFA-funded research activities:
The report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts that the GDUFA Science and Research program awarded in FY2019.
- Joint Directors’ Message
- Abuse-deterrent Opioid Drug Products
- Complex Injectables, Formulations and Nanomaterials
- Complex Mixtures and Peptides
- Data Analytics
- Drug-Device Combination Products
- Inhalation and Nasal
- Locally-Acting Physiologically-Based Pharmacokinetic Modeling
- Long-Acting Injectables and Implants
- Ophthalmic
- Oral Absorption Models and Bioequivalence
- Patient Substitution
- Quantitative Clinical Pharmacology
- Topical Dermatological
MORE RESOURCES:
United States’ FDA