Drugs

Identify Barriers to Enrolling Trial Subgroups: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates the work FDA has done on advancing the inclusion of diverse populations, including racial and ethnic minorities, in clinical trials. Commenting to the agency docket on strategic priorities for the FDA Office of Minority Health and Health Equity, PhRMA says it is important to “identify barriers to enrollment of underrepresented demographic subgroups in clinical trials and employ strategies to encourage greater participation, while also ensuring an efficient drug development process.”

The association suggests that the Office of Minority Health and Health Equity and the biopharmaceutical industry work together to identify and share best practices to advance clinical trial diversity. “PhRMA suggests that this list of best practices includes strategies to increase trust and decrease stigma towards the medical profession, as well as minimize barriers to clinical trial participation while also addressing recruitment and retention of diverse populations,” the group says.

The comment letter also includes specific recommendations.

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