|CAPT Jason Woo, MD, MPH, FACOG|
Senior Medical Officer
CDER/Office of Generic Drugs/Immediate Office
Bldg 75, Rm 1700
10903 New Hampshire Ave
Silver Spring, MD, 20993
MD, MPH, FACOG
Product development, manufacturing and quality assurance. Understanding the critical product attributes for ensuring generic consistency and equivalence.
Generic drug review criteria and effective communication of submission deficiencies. Understanding the consistency of identified review deficiencies and communication of them in a manner leading to decreased cycles to approvability.
Proposed Research Project for FDA Commissioner's Fellow
The incentive for the establishment of the initial Generic Drug User Fee Agreement was the significant rise in the “backlog” of Abbreviated New Drug Applications and the increasing time from submission to approvability. While GDUFA I and GDUFA II have brought significant resources and improvements to the FDA’s generic drug review program, the overall number of ANDA submissions still pending approval has increased since the start of GDUFA I. Lessons from the progression of improvement under PDUFA have demonstrated the importance of improving communications with sponsors in order to increase the rate of first cycle approvals and overall decreasing time to approvability. This project will seek to clarify the “quality” of the current review process of ANDA submissions under GDUFA and identify review characteristics and communications that may contribute to delays in getting ANDAs to approvability status.
Beginning with background data on action rates and common deficiencies from the first year of ANDA submissions with 15 month goal dates (Cohort Year 3 under GDUFA I), the fellow will analyze and compare approvals and Complete Response (CR) reviews to identify review criteria, deficiency descriptions and communication practices that help or hinder subsequent amendment submissions and approvability actions. Areas of focus will include:
- Discipline reviews and consistency in accordance with ANDA submission requirements among and across common drug product submissions
- Classification and communication of deficiencies that facilitate adequate and timely responses from sponsors
- Identification of best practices for development of internal process or policy documents
Outputs from this project will include publication of summary results to communicate current generic drug review trends and areas for possible continued improvement. The projected outcome will be both internal and external improvements in communication practices that lead to decrease time to ANDA approvability and volume of pending ANDA applications.
Manufacturing sciences advanced degree (Chemistry, Pharmacology, Toxicology, Microbiology, Statistics or other manufacturing quality control experience). Understanding of basic statistical approaches and data management systems.
Selected Recent Publications
1. Yu LX, Woodcock J. FDA Pharmaceutical quality oversight. Int J Pharm. 2015 Aug1;491(1-2):2-7. [PMID: 26027494]
Gupta R, Kesselheim AS, et al. Generic drug approvals since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Sep 1;176(9):1391-2. [PMID: 27428055]
2. Rayavarapu S, Braithwaite E, et al. Comparative risk assessment of formulation changes in generic drug products: a pharmacology/toxicology perspective. Toxicol Sci. 2015 Jul;146(1):2-10. [PMID 26101235]
3. Peters JR, Hixon DR, et al. Generic drugs – safe, effective, affordable. Dermatol Ther. 2009 May-Jun;22(3):229-40. [PMID: 19453347]