Drugs

Combination Product Postmarketing Reporting

FDA says it is releasing a draft guidance to provide more complete and relevant information on the process for submitting postmarketing safety information on combination products. FDA commissioner Scott Gottlieb says the guidance “explains when a single, complete report can be used to meet multiple reporting requirements and what the requirements are for sharing safety information with co-applicants of a combination product. Combination products, like continuous glucose monitors combined with insulins pumps to act as an artificial pancreas for patients, present significant opportunities for innovation and improvement in patient care. Today’s action will help sponsors comply with important FDA regulations on postmarketing safety reporting for these products.”

A Federal Register notice says the draft guidance, Postmarketing Safety Reporting for Combination Products, addresses certain means by which applicants may comply with the 12/20/16 final rule on postmarketing safety reporting (PMSR) requirements for combination products. Major provisions of the final rule discussed in the guidance are: application-type based PMSR, constituent part-based PMSR, information sharing, submission process for combination product PMSR information, and records retention.

A second Federal Register notice announces the availability of an immediately in effect guidance, Compliance Policy for Combination Product Postmarketing Safety Reporting.

Gottlieb says the two documents are intended to ensure that “the process for submitting safety information to FDA is clear, efficient, and promotes timely evaluation of potential safety issues.”

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