Drugs

FDA Piloting New Combination Product Consult Process

FDA officials say the agency will begin piloting a new inter-Center consult request (ICCR) procedure for proposed combination products. In a new agency blog post, they say that “close inter-Center collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review. A combination product will generally have a lead Center which may seek consults from the other Centers that oversee one of the product’s constituent parts. Timely and consistent consults are critical, yet achieving this has been challenging due to different policies, practices, and timelines for consults across Centers and insufficient communications between Centers and sponsors.” Under the pilot, the following four new process improvements will be evaluated:

Establishing timelines, specific to Center and submission type, for identifying products as combination products and issuing and completing consults needed to support the review;
Developing a tiered consult approach that streamlines interactions across Centers and identifies a clear process for identifying the right experts for a consult;
Defining clear roles and responsibilities for the lead Center, the consulted Center(s), the Office of Combination Products, and the Combination Product Council for reviewing a combination product submission; and,
Creating a standard, semi-automated, user-friendly ICCR form that is managed electronically to ensure users always have the most updated version and all forms and consults are tracked through a single system.

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