Post-Approval Considerations For Changes To Manufacturing Process And Facilities - Redi 2020

Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020

U.S. Food and Drug Administration

Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020

U.S. Food and Drug Administration

Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020

U.S. Food and Drug Administration

Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020

U.S. Food and Drug Administration

Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020

U.S. Food and Drug Administration

So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020

U.S. Food and Drug Administration

FDA Drug Manufacturing Inspections - REdI 2020

U.S. Food and Drug Administration

ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues

U.S. Food and Drug Administration

Chemistry Manufacturing Control (CMC), Post approval changes- Regulatory Affairs

SBIA Program Overview - REdI 2020

U.S. Food and Drug Administration

Manufacturing Process and Controls: Avoiding Assessment Issues (26of28) GDF – Apr. 3-4, 2019

U.S. Food and Drug Administration

Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020

U.S. Food and Drug Administration

FDA Regulatory Education for Industry (REdI) Annual Conference 2023 – Plenary + Drugs Day 1

U.S. Food and Drug Administration

How Does FDA Execute Pre- and Post-approval Inspections? (7of33) Quality – Oct. 16-17, 2019

U.S. Food and Drug Administration

REdI Annual Conference 2024: CBER (Biologics) Innovation in Medical Product Development (Day 2 of 2)

U.S. Food and Drug Administration

Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence

U.S. Food and Drug Administration

Comparability protocol for Post Approval Changes, Manufacturing and Controls Information

Post Approval Stability Studies

Pharma Best Practices Webinars

Regulatory Education for Industry (REdI) Annual Conference 2023 – Day 2 – Session 4 and Closing

U.S. Food and Drug Administration

ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020

U.S. Food and Drug Administration