GDUFA Research Outcomes

Other Generics Research

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.

• All(57)
• Posters(10)
• Presentations(44)
• Papers(3)

• Regulatory Perspective of Model Master Files Utilities for Oral Drug Products

  Wu, Fang

• Statistical Experience and Challenges In Assessing Similarity Of Dissolution Profiles, Particle Size Distributions and API Sameness

  Tsong, Yi

• Considerations and Potential Regulatory Applications for a Model Master File

  Tsakalozou, Eleftheria

• International Engagement with OGD Parallel Scientific Advice (PSA) Process

  Sarago, Caliope

• GDUFA III Product-Specific Guidance (PSG) Teleconferences

  Sarago, Caliope

• Overview of Pre-ANDA Meetings Under GDUFA III

  Nigam, Savita

• Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III

  Monroy-Osorio, Maria

• Considerations for Medical Scientists: Product Development, Career Development and Regulatory Science

  Luke, Markham C

• Overview of the GDUFA Research Portfolio

  Lionberger, R

• Predicting Formulation Performance: Learning from Generic Drugs

  Lionberger, Robert