Drugs

FDA Efforts to Speed Covid-19 Treatments

FDA commissioner Stephen Hahn, CBER director Peter Marks, and CDER director Janet Woodcock say the agency has streamlined its review and advice process to get studies of potential Covid-19 treatments started as quickly as possible. Writing in an online FDA Voices post, the three say that under the agency’s Coronavirus Treatment Acceleration Program there are 72 clinical trials of potential therapies underway with FDA oversight.

“Studies like these help us find out if products work against Covid-19 and assess toxicity,” the post says. “Both the pharmaceutical industry and academic researchers have submitted many innovative and well-designed studies for the prevention and treatment of Covid-19.”

The post describes some of the studies and says that data from some of them should become available soon. “We intend to use a flexible and innovative approach” once the data come in, the three say. “Once we observe favorable results, we intend to be very proactive about patient access.”

The post also discusses agency efforts to facilitate Covid-19 vaccine development.

“FDA has experts standing ready to continue to work with product developers of products to prevent and treat Covid-19,” the executives conclude. “We urge product developers to take full advantage of our pre-IND consultation program and the INTERACT program. These programs provide expert advice to navigate scientific and regulatory challenges and expedite product development.”

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