Tag: CDER

Introduction to FDA's Office of Trade and Global Partnerships

U.S. Food and Drug Administration

Introduction to FDA's Office of Trade and Global Partnerships

U.S. Food and Drug Administration • Available on Youtube • Published 2 months ago

Generic Drugs Forum (GDF) 2024: Regulatory considerations to improve access to generics – Day 1, Part 1

U.S. Food and Drug Administration

Generic Drugs Forum (GDF) 2024: Regulatory considerations to improve access to generics – Day 1, Part 1

U.S. Food and Drug Administration • Available on Youtube • Published 2 months ago

Dataset JSON pilot report and next steps

U.S. Food and Drug Administration

Dataset JSON pilot report and next steps

U.S. Food and Drug Administration • Available on Youtube • Published 2 months ago

Update of Study Data Standards for CBER: Your Guide to a Successful Submission

U.S. Food and Drug Administration

Update of Study Data Standards for CBER: Your Guide to a Successful Submission

U.S. Food and Drug Administration • Available on Youtube • Published 2 years ago

Risk assessment of biopharmaceuticals as a guide for the development of dissolution processes for solid oral dosage forms

U.S. Food and Drug Administration

Risk assessment of biopharmaceuticals as a guide for the development of dissolution processes for solid oral dosage forms

U.S. Food and Drug Administration • Available on Youtube • Published 3 years ago

Planning the joint development of companion diagnostics

U.S. Food and Drug Administration

Planning the joint development of companion diagnostics

U.S. Food and Drug Administration • Available on Youtube • Published 3 years ago

Data Integrity Overview (4 of 11) GCP Data Integrity Workshop

U.S. Food and Drug Administration

Data Integrity Overview (4 of 11) GCP Data Integrity Workshop

U.S. Food and Drug Administration • Available on Youtube • Published 4 years ago

Data Integrity from an International Perspective (2 of 11) GCP Data Integrity Workshop

U.S. Food and Drug Administration

Data Integrity from an International Perspective (2 of 11) GCP Data Integrity Workshop

U.S. Food and Drug Administration • Available on Youtube • Published 4 years ago