Drugs

Woodcock to Testify at Hearing on Improving OTC Monograph Process

CDER director Janet Woodcock is scheduled to testify before a 9/13 House Energy and Commerce Subcommittee on Health about “Modernizing FDA’s Regulation of Over-the-Counter Drugs.” The hearing is intended to provide members an opportunity to better understand the current framework in place at the agency for regulating over-the-counter (OTC) drug products and to consider a bipartisan proposal to improve the OTC monograph process. “FDA began evaluating twenty-six therapeutic categories of OTC drug products in 1972 and has yet to finalize monographs for each of them,” a background memo says. “Due in large part to the multi-phase public rulemaking process required even for changes to the monograph such as label warnings or new dosage forms, the current process is inefficient and does not enable product advancements to reach consumers quickly.”

In 2016, FDA held a public meeting and received stakeholder input on establishing a more flexible process funded by industry user fees. Based on negotiations between FDA and industry, several House members have developed a draft legislative proposal that would authorize a new and improved regulatory framework at FDA, 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