Drugs

CDER Plans New Guidances on Combos, Quality Metrics

CDER says it will develop a guidance this year on “Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA.” The Center disclosed the new guidance in a periodic update to its Guidance Agenda. Combination product review processes and procedures have recently been getting more attention at the agency, with officials last month announcing a new pilot on inter-Center consult request (ICCR) procedures for proposed combination products (see story). An agency blog post noted 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.”

The guidance agenda also noted that CDER has decided to scrap its 2015 draft guidance on Request for Quality Metrics, and plans to replace it with a revised draft document later this year on Submission of Quality Metrics Data. “After carefully considering the numerous technical and regulatory comments received to the docket for the initial draft guidance,” an FDA spokesperson told FDA Webview, “FDA intends to issue a revised draft guidance to outline a revised program that incorporates many of the substantive stakeholder comments. The revised draft guidance, when issued, will be accompanied by another open comment period to gain further stakeholder input in the revised program.”

Pharmaceutical Research and Manufacturers of America has been critical of CDER’s quality metrics plan (see story). The group said the agency should provide more transparency on how it plans to process, interpret, and use the data. It also urged FDA to clarify that it will continue to protect manufacturers’ confidential commercial information when it collects quality metrics data. “Such information must continue to be protected in order to avoid unintended consequences if the data were taken out of context, misinterpreted or misused,” it said. “PhRMA has requested that FDA explicitly state it will protect biopharmaceutical companies’ confidential commercial information when used as part of the quality metrics program.”

Additionally, PhRMA called on FDA to phase-in the program to make it possible to incorporate lessons learned by stakeholders over time. “A phased-in approach … would help to balance the potential benefits with any unnecessary burden for both the agency and industry so that we can both continue to meet our shared goal of protecting and promoting patient health,” the group said.

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