FDA Policy/General

White House Seeks FDA Innovation, Competition Funds

FDA commissioner Scott Gottlieb says the administration’s budget request provides the agency with the resources to continue to fund its current programs at consistent levels and also seeks $400 million in additional funding “to advance planned initiatives to further promote innovation and competition and advance the health and safety of American families.” In a statement, Gottlieb says the new resources will help advance initiatives to support novel medical technology and public health priorities such as generic drug development, pharmacy outsourcing, and novel domestic manufacturing capabilities.

Some of the initiatives he cites are:

promoting domestic manufacturing through development of efficient regulatory pathways;
advancing a new domestic drug industry and promoting access by establishing the outsourcing facility sector as a robust and reliable source of compounded products;
bringing medtech manufacturing home;
creating a new medical data enterprise;
facilitating growth and spurring transformation of the digital health technology industry by shifting regulation to an efficient and novel framework for reliable post-market oversight;
creating a new platform for how the agency more efficiently develops and validates modern science-based principles for new drug development and shares the information with innovators;
stimulating investment in and innovation of medical products targeted to rare diseases; and
modernizing generic drug development and review.

“We are grateful for the administration’s support of these initiatives and believe these new investments in our agency’s mission will ultimately lead both to better health outcomes for American families and to greater U.S. economic development,” Gottlieb concludes.

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