FDA Policy/General

FDA, SEC Sign MOU on Sharing Info on Medical-Product Companies

FDA and the U.S. Securities and Exchange Commission have agreed to strengthen cooperation and share information involving companies and products regulated by the agency. Under a new three-year memorandum of understanding, the agencies will establish procedures for exchanging both public and certain non-public information when it is relevant to their regulatory and enforcement responsibilities.

The agreement is intended to help the SEC evaluate whether firms are making accurate disclosures about matters such as FDA reviews, product approvals and clinical trial results. It also provides for secure exchanges of confidential information and sets restrictions on its further disclosure.

Both FDA and SEC said the arrangement is designed to improve regulatory oversight while protecting confidential business and other legally protected information. Acting FDA commissioner Kyle Diamantas said greater information-sharing would help protect patients and strengthen public trust in the life-sciences sector.

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