FDA Policy/General

FDA Must Cut 2 Existing Regs for Each New Rule Introduced

President Donald Trump 1/30 signed an executive order requiring FDA and other government agencies to eliminate two existing regulations for every new rule introduced. “This will be the biggest such act that our country has ever seen,” Trump said in a signing ceremony. “There will be regulation, there will be control, but it will be normalized control.” The order does not require that the repeal of the two regulations be done simultaneously with the release of additional rules.

The order also calls for a process for the Office of Management and Budget (OMB) to set an annual cap on the cost of new regulations. For example, for the rest of fiscal 2017, the cap will require that the cost of any additional regulations be completely offset by reversing existing rules. Additionally, regulations affecting the military and national security are waived under the order.

There is some wiggle room in the order — the OMB director can waive the policy in certain instances.

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