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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Methotrexate interactions to avoid

The Checkup by Singlecare

Prescribing information for both probenecid and methotrexate mentions the risk of developing severe adverse reactions when these medications are taken concomitantly.

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Methylprednisolone interactions to avoid

The Checkup by Singlecare

Many drug interactions are related to additive adverse reaction profiles with concomitant medications with similar side effect profiles. Sources Effects of oral corticosteroids on chronic warfarin therapy , The Annals of Pharmacotherapy (2006) Corticosteroids and ulcers: is there an association ?,