MMS Holdings Expert Insights Blog

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

A Recap of 2022’s Orphan Drug Approvals

A Recap of 2022’s Orphan Drug Approvals

In the US, a rare disease is defined as one that affects less than 200,000 people. While these specific diseases are considered rare, living with a rare disease is not. In the US alone, over 30 million people are living with 7,000 different types of rare diseases.1 A...

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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 FDA recently announced the availability of a revised draft Guidance for industry on expanded access (EA) to investigational new drugs (INDs) for treatment use, which consists of...

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