Drugs

FDA Modernizing GCP Guidelines: Attorneys

Three Morgan Lewis attorneys say an updated FDA draft guidance to implement the International Council for Harmonizations good clinical practice (GCP) guidelines is part of a series of agency documents demonstrating its interest in modernizing the guidelines to account for emerging technologies. An online post says FDA’s receptivity to new technologies, acknowledgment of decentralized clinical trial sites, and the outsourcing of clinical trial functions “does not indicate that FDA will reduce the need for control over these innovations. Sponsors will have to be equally innovative in developing control mechanisms to ensure continued protection of human subjects and data integrity.”

The attorneys write that the agency’s focus on digital health technologies and on processes and procedures for promoting data integrity “should be considered in light of the agency’s determination to place compliance obligations on a wider range of parties involved in clinical research throughout the trial process, including contractors that provide biostatistical support, data scientists, and data managers. Sponsors, contract research organizations, and third parties will also have to ensure ongoing compliance with FDA’s GCP expectations.”

Comments on the draft guidance will be received until 9/5.

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