Skip to content

All Lessons

503B Pre-Operational Evaluations: A First Step to Compliance

Accelerating Medical Device Innovation with Regulatory Science Tools

Achieving Fit-for-Purpose Clinical Trial Quality

Advanced Manufacturing Technologies (AMT) Designation Program 

Advancing Innovation in Healthcare with Combination Products

AI in Drug Development

An Innovative Approach to Navigating the Quality Management System Regulation (REdI 2024 – Devices Track)

Analytical Inspections for Bioavailability/Bioequivalence Studies

ANDA Common Major Deficiencies

ANDA Missed Goal Dates: An Update on Metrics and Internal Communications

Artificial Intelligence (AI) | Machine Learning (ML): The New Frontier of Drug Development and Regulation 

Artificial Intelligence Challenges for Regulating Vaccine Development

Assessment of Inactive Ingredients in Generic Drug Applications: Building a Global Understanding

Awardee Presentations for Internal Research  (BsUFA III Science Pilot Program: Progress Update)

Basics of Clinical Design

Best Practices for Generic Drug Labeling

Bioequivalence Approaches for Nitrosamine Impacted Generic Drug Applications: Case Studies

Blood Regulation and Safety (REdI 2024 – Biologics Track)

BsUFA Program Introduction & Recap from Last Engagement  

Call To Action

Case Studies (Electronic Drug Registration and Listing 2024)

Case Studies of Using Alternate Reference Products or Alternative Bioequivalence (BE) Approaches in Abbreviated New Drug Application (ANDA) Submissions

CBER Presentations (FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA)

CBER Question & Answer Session (FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA)

CBER Track Welcome (REdI 2024 – Biologics Track)

1 2 3 … 13
Share: