FDA Policy/General

FDA Touts U.S.-Canada RCC Achievements

Writing in a From a Global Perspective article, two staffers from the FDA Global Engagements Team and one from CVM outline several of the successes that have occurred under the U.S.-Canada Regulatory Cooperation Council (RCC) that was created 10 years ago. The article notes that even before the RCC, FDA, Health Canada, and the Canadian Food Inspection Agency already had an excellent working relationship, including a pre-standing confidentiality arrangement for information sharing along with other Memoranda of Understanding in various topics.

“The RCC provided an avenue for further collaboration on regulatory alignment and stakeholder engagement in the areas of food safety, pharmaceuticals, biologics, veterinary drugs, and medical devices,” the post says.

After reviewing several success stories, the authors say that the Global Engagements Team and agency Centers will continue to collaborate closely with their Canadian counterparts to ensure that the commitments outlined in the work plans remain current and relevant. “In alignment with broader international harmonization goals, FDA and Health Canada are collaborating to develop foundational building blocks for a Medical Device Single Review Program,” the post says. “This program will offer medical device manufacturers the opportunity to receive a single premarket review (for eligible devices) that satisfies the relevant requirements of multiple countries, including the U.S. and Canada.”

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