Drugs

FDA Boosts Translational Sciences ‘Achievements’

The CDER Office of Translational Sciences (OTS) says it “works collaboratively to help drive advancements in human health through scientific and regulatory innovation.” The OTS 2022 annual report says its tasks have included:

promoting scientific collaboration and innovation in drug regulatory review across CDER;
assuring the validity of clinical trial design and analysis in regulatory decision-making;
developing and applying quantitative and statistical approaches to decision-making in the regulatory review process;
ensuring alignment of CDER research and Center goals;
serving the CDER scientific community in establishing technology transfer agreements that are vital to collaboration with the broader scientific community;
maintaining knowledge management databases that can be the basis of improvements in the regulatory review process; and
overseeing bioavailability/bioequivalence and nonclinical inspections to help ensure the availability of safe and effective new and generic drugs.

Apparently an effort to boost internal morale, the 25-page report devotes 13 pages to what it calls the office’s 2022 “achievements in drug regulatory review; inspections; science and research; advancing tools, technologies, and innovation; and outreach and communication efforts.

To be more impressive, next year’s OTS annual report might translate its achievements into plain language using actual meritorious examples.

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