FDA Law Blog: Biosimilars

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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. Increased Connections Between a DMC and FDA?

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Documentation Adverse Reactions Communication Drug Development 105

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

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Documentation Communication Mayo Clinic Drug Development 52

PharmaTech

JUNE 23, 2025

Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs. It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties.

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Compounding Dosage Labelling Drug Development 52