MMS Holdings Expert Insights Blog

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

FDA Updates IND Expanded Access Guidance for Industry

FDA Updates IND Expanded Access Guidance for Industry

New recommendations for IRB review, informed consent and expanded access policies. FDA recently announced the availability of a revised draft Guidance for industry on expanded access (EA) to investigational new drugs (INDs) for treatment use, which consists of...

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What is Regulatory Information Management System (RIMS)?

What is Regulatory Information Management System (RIMS)?

Regulatory Information Management Systems Software (RIMS) are centralized platforms designed to support and streamline Regulatory Affairs teams and operations. RIMS helps in the creation, organization, submission, and archival of regulatory information in regulated...

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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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