Drugs

Academy Urges Broader Info Sharing Among Regulators

A new report by the National Academy of Sciences recommends that regulators like FDA “need to make increased use of reliance and cooperation with other trusted regulators, as no regulator has the resources it needs to meet all of its public health responsibilities.” The report also said “(i)mpediments to regulators entering into and using such informal and formal recognition and reliance arrangements to help them obtain the information they need for their regulatory decision making should be removed.”

The report, Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators, recommends that all regulatory authorities “should be allowed to share their work products in essentially unredacted form (i.e., full reports without parts of the report expunged, except for personal privacy information) with other regulatory authorities so assessment and inspection information can be made available to other regulators, especially lower-resourced regulators, to enable access to quality, useable regulatory information by a greater number of regulatory authorities for addressing global public health needs.”

The report says that for FDA, Congress should weigh the challenges and opportunities involved with empowering the agency to share complete unredacted GMP inspection reports with other regulatory authorities that would “facilitate learning, aid in decision-making, reduce the use of limited resources on redundant inspections, decrease the burden on industry of redundant inspections, and strengthen the overall global public heath infrastructure for safe and effective quality medicines.”

Additionally, the report recommends that regulatory authorities in the U.S. and the EU immediately begin considering the potential for expanding the EU-U.S. mutual recognition agreement to include reliance in areas beyond GMPs and a broader scope of products under the current GMP provisions.

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