MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

Updates to FDA Meetings under PDUFA VII

Updates to FDA Meetings under PDUFA VII

Sponsors receive FDA feedback and advice on their drug development program via formal FDA meetings. These meetings allow Sponsors to learn the FDA's current thinking on a specific topic and to amend their development program based on FDA's recommendations...

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Drug Safety Updates: What’s New Under PDUFA VII?

Drug Safety Updates: What’s New Under PDUFA VII?

Patient safety remains at the forefront of the FDA's intentions to continue and enhance existing drug safety programs and develop new ones under PDUFA VII. Commitment to Enhanced Communication on Risk Management Activities During Review  Some of the planned...

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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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