LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.
|Articles|May 15, 2017
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
Quality Metrics and CMO Agreement
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
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As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues. Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.
Articles in this issue
over 9 years ago
Customer Relationship Management in Contract Manufacturingover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
CMOs Tackle New Challengesover 9 years ago
Gearing Up for Biosimilarsover 9 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyover 9 years ago
Operations and Quality Oversight of CMOsAdvertisement
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