Drugs

Ways to Increase Clinical Trial Diversity: PhRMA

In comments to the White House Office of Science and Technology Policy (OSTP), Pharmaceutical Research and Manufacturers of America (PhRMA) presents three ways to increase diversity in clinical trials. PhRMA says OSTP solicited stakeholder feedback on the clinical research infrastructure for emergency clinical trials.

The trade association says it shares OSTP’s recognition of the importance of having a clinical trial infrastructure that supports sites that are ready to respond to emergencies like Covid-19. “We also agree that one goal of such an infrastructure should be to support the expansion of clinical research into underserved communities by increasing diversity among both trial participants and clinical trial investigators,” it says.

The PhRMA comments present its views on:

expanding clinical research sites in underserved areas;
using decentralized clinical trials and digital health technology innovations; and
having a network of sites in a state of readiness to undertake additional or future clinical research.

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

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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