Drugs

Integrating RCTs into Routine Clinical Practice

FDA has published a guidance, Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, that is intended to support the conduct of randomized clinical trials (RCTs) with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. The document says that leveraging established healthcare institutions and existing clinical expertise in the medical community can reduce startup times and speed trial enrollment.

The guidance applies to studies involving FDA-approved drugs being studied for new indications, populations, routes of administration, or doses; drug safety studies for FDA-approved drugs; other postmarketing studies for FDA-approved drugs; comparative effectiveness studies for FDA-approved drugs; and trials of unapproved drugs when the safety profile is sufficiently characterized and the drug is appropriate to be administered and managed in the setting of routine clinical practice. The guidance does not address non-interventional studies.

FDA says sponsors are encouraged to employ a quality-by-design approach to achieve the scientific objective and ensure adherence to FDA requirements, including those relating to good clinical practice. “Regulatory requirements for trials integrated into routine clinical practice are the same as those for traditional clinical trials,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome