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FDA

Process Improvement

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Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

The FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Opportunity for feedback from FDA if provided pre-BLA. By Holly N.

FDA

FDA Process Improvement

Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/examples-accepted-emerging-technologies 26 Eisner, D.

Health and Personal Care Stores

Health and Personal Care Stores Vaccines Packaging Documentation

Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

Considerations for a Decentralized Manufacturing Paradigm

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