Drugs

Expand RTOR to Cell, Tissue Products: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should expand the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program to include human cell and tissue products regulated by CBER and products using digital health technologies in support of their applications. Commenting on an agency RTOR draft guidance, PhRMA says it appreciates the stepwise approach OCE has taken to initially implementing RTOR.

“By piloting the program with supplemental applications for products with which FDA had prior experience and which had robust safety data,” the association says, “and then expanding the program to include full applications, FDA and sponsors gained more experience with and confidence in the RTOR process.”

PhRMA also noted there are differences in key elements provided on the agency RTOR Web site and the draft guidance and said OCE should provide additional clarity for the RTOR process by aligning the Web site information with the guidance. It also provided specific comments.

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