Drugs

FDA Wants Regulatory Science Collaborators

Three FDAers say many researchers are unaware of FDA regulatory science research opportunities and the need for collaboration. Writing in Trends in Pharmaceutical Sciences, the three say the agency has “multiple avenues for collaborative research including participation in public-private partnerships, working with consortia, implementation of research collaboration agreements with academics and industry, and sponsorship of extramural research via Centers for Excellence in Regulatory Science and Innovation, and Broad Agency Announcement funding mechanisms and other contracts and grants.”

The article defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. It says that conducting and supporting regulatory science efforts are critical to achieving FDA’s mission.

The authors say that FDA scientists can use their unique perspective to help create a foundation or direct development of a tool, or identify regulatory uses for tools developed by academia or industry. However, the article says, agency scientists need the efforts of multiple stakeholders to complete the translation of new tools into the drug development and evaluation process.

“Applied regulatory science is a largely overlooked component of translational science that has not historically received substantial grant support or been published in the top scientific journals,” the article concludes. “However, regulatory science can have a tremendous public health impact. Scientists from all segments of the research community are called to rally to regulatory priorities to deliver innovative new therapies at more affordable cost to patients and society.”

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