Drugs

Takeaways from Clinical Trial Enforcement Panel

Four Morrison Foerster attorneys say a panel on “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement” held on 11/2 at a Food and Drug Law Institute conference featured a high-ranking attorney from the Department of Justice consumer protection branch and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement. In an online post, they list these takeaways:

confirmation that the Justice Department is looking not only at the activities of individuals, but also big corporate actors with a specific focus on the submission of false and misleading data to FDA and obstruction of FDA and other regulators;
pursuing cases under the Federal Food, Drug, and Cosmetic Act, including felony or misdemeanor criminal actions;
FDA inspection classification does not determine whether the Justice Department will bring an action;
special attention to cybersecurity and digital enrollment; and
steps sponsors and other corporate actors can take to mitigate department enforcement risk.

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