Drugs

Combo Product Proposed Rule Offers More Transparency

FDA has released a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process. The proposal is intended to streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. “These regulations address the process for obtaining answers to important initial questions for medical product developers, including what type of medical product they are seeking to develop and market and which agency component will have the lead for premarket review and regulation,” an agency notice says. “Providing a mechanism to address these questions when the answers may be unclear or in dispute enables developers to understand the regulatory expectations and processes that will apply, which can be important to product development planning.”

The proposed rule provides industry with greater transparency about the agency’s classification and Center assignment process for such products. For example, it would align the regulations with more recent legislative and regulatory measures and remove out-of-date advisory content that does not accurately reflect current agency practices and policies. Comments on the proposal are being accepted for 60 days.

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