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All Lessons

FDA Welcome and Keynote (REdI 2024 Conference)

FDA’s Good Clinical Practice Compliance Review for NDAs and BLAs

FDA’s M13A Implementation for Generic Drug Applications: Focus on PSG Revisions (Additional M13A and Other Revisions)

FDA’s M13A Implementation for Generic Drug Applications: PSG Revisions to Align with M13A

FDA’s Use of Alternative Approaches to Evaluate GCP Compliance

Fiscal Year 2025 OMUFA Fee Schedule

Foundations of Medical Device Regulation in a World of Change

GDUFA III Impact on Drug Master File (DMF) Assessment

General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration

GIDWG Global IDMP Identifiers

Global IDMP Implementation: Getting Closer to the Goal

Global IDMP Implementation: Readiness

Global Market Innovation with Medical Device Export Certificates

HCT/P Donor Screening/Testing and Requests for Exemption (REdI 2024 – Biologics Track)

How to Leverage the Inactive Ingredient Database (IID) and Safety Justification

Impact of ICH M13A Implementation on Bioequivalence Assessment: Removal of Data Due to Low Exposure

Informed Consent: More Than Just a Document

Innovations in Medical Device Remanufacturing and Servicing

Innovative Approaches to Clinical Trials

Innovative Approaches to Emerging Threats

Innovative Therapeutics: Gene Therapy (Clinical Investigator Training Course 2024)

International Clinical Trials

Introduction and Overview of the Model Master File  

Investigator Responsibilities – Regulation and FDA Expectations for the Conduct of Clinical Trials

Key Information in Informed Consent (Clinical Trials) 

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