GDUFA Research Outcomes

Other Generics Resaerch

• All(111)
• Posters(8)
• Presentations(90)
• Papers(13)

• Evaluating Therapeutic Performance of Complex Generic Drugs for Pulmonary Delivery: The FDA Generic Drug Approval Process

  Luke, Markham

• Careers in Pharmacology Symposium: The FDA

  Luke, Markham C

• Complex Generics 2022 Update

  Lionberger, Robert

• Suitability Petitions Enable Generics

  Lionberger, Robert

• Critical Roles of Excipients in the Development of Generic Drug Products

  Lionberger, Robert

• Complex Generics Town Hall

  Lionberger, Robert

• Workshop Introduction

  Lionberger, Robert

• Keys to Success for Complex Generics

  Lionberger, Robert

• Harmonization of Bioequivalence FDA Perspective

  Lionberger, Robert

• Opportunities Provided by the ICH Reflection Paper for Generics

  Lionberger, Robert