Drugs

CARES Act OTC Monograph Provisions Explained

A Hyman, Phelps & McNamara 4/6 memo summarizes the OTC Monograph Drug Review Reform provisions that were included in the Coronavirus Aid, Relief, and Economic Security Act of 2020. The memo says OTC monograph reform legislation that has been stalled in Congress for more than two years found its way into the CARES Act.

“The OTC monograph reform legislation has been supported by both FDA and regulated industry as a means to modernize the, what some people have identified as archaic and cumbersome, existing OTC monograph system which had become bogged down by the requirements of the rulemaking process, limited resources, and other constraints,” the memo says.

It says the overarching purpose is to move the OTC monograph drug review framework from one of notice and comment rulemaking to an administrative order process exempt from certain requirements of the Administrative Procedures Act. Also, the legislation is designed to provide for innovation such as additional active ingredients, new indications, and new dosage forms. And it is intended to give FDA the means to more quickly respond to and address safety concerns, the memo says.

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