MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
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CMC and Quality Enhancements Under PDUFA VII Explained

CMC and Quality Enhancements Under PDUFA VII Explained

FDA establishes numerous enhancements to product quality and chemistry, manufacturing, and controls (CMC) approaches in PDUFA VII to facilitate timely access to safe, effective, and innovative new medicines for patients, including: product quality reviews; CMC...

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