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All Lessons

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

Case Studies: Glatiramer Acetate Subcutaneous Injectable and Pentosan Polysulfate Oral Capsules

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)

CBER’s Perspective on Evaluation and Implementation of Rapid Microbial Methods

CBER’s Advanced Manufacturing Programs for Sponsors

CDER Bioresearch Monitoring (BIMO) Requests for New Drug and Biologic Licensing Applications

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

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

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

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

Celebrate Achieving Result

Cell Therapies for Niche Indications: Clinical Insights and Future Directions: Discussion Panel

Cell Therapies for Niche Indications: Clinical Insights and Future Directions: Presentations

Certificates of Confidentiality: FDA | CDER Issuance of Discretionary Certificates of Confidentiality

Certificates of Confidentiality: General Overview

Chemistry, Manufacturing and Controls: Regulatory Considerations Through Clinical Development

Cleanroom Gowning: 5 Common Mistakes and How to Address

Clinical DDI Assessments (ICH M12 Drug-Drug Interaction Studies)

Clinical Inspections for Bioavailability/Bioequivalence Studies

Clinical Investigator Inspection Readiness

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