Drugs

Updated ICH Good Clinical Practice Guidance

FDA has published the International Council for Harmonization (ICH) E6(R3) draft guidance Good Clinical Practice (GCP) with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials. An agency notice (contains a link to the guidance) says the draft was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.

“The objective of this ICH GCP guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities,” the document says.

The guidance applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities. It says it may also apply to other interventional clinical trials of investigational products that are not intended to support marketing authorization applications following local requirements.

The guidance includes principles and annexes that expand on the principles, with specific details for different types of clinical trials. “The principles are intended to apply across clinical trial types and settings and to remain relevant as technological and methodological advances occur,” it says. “The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial.”

Once finalized, the draft will update an existing 2018 IHC guidance. FDA says the draft will be open for public comment for 60 days. The ICH Expert Working Group that developed the draft will review and consider the comments as well as feedback from other ICH members before finalizing the guidance.

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’

Overton Confirmation Remains Uncertain After Senate Hearing

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

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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

Read more

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