Drugs

Manufacturer Economic Info Communications Q&A Guidance

FDA has published a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis. The document also addresses common questions relating to the dissemination to payors of information about medical products that are not yet approved or cleared for any use, and dissemination to payors of information about unapproved uses of approved/cleared medical products.

When finalized, the draft will replace a 6/2018 final guidance.

The questions and answers are grouped into two categories: (1) communication of HCEI to payors regarding approved/cleared medical products, and (2) communications to payors about unapproved medical products and about unapproved uses of approved/cleared medical products.

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