Drugs

Office of Translational Sciences Annual Report

The CDER Office of Translational Sciences 2023 annual report says it highlights achievements in the areas of drug regulatory review; inspections; science and research; advancing tools, technologies, and innovation; administrative operations; and outreach and communication efforts. Activities discussed in the report include:

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;
overseeing bioavailability/bioequivalence and nonclinical inspections to help ensure that safe and effective new and generic drugs are available;
aligning the research at CDER with the Center’s goals;
facilitating the establishment of technology transfer agreements for collaboration with the broader scientific community; and
maintaining knowledge management databases for improvements in the regulatory review process.

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