Drugs

CTAP Has Reviewed Over 230 Covid Trials: Hahn

FDA commissioner Stephen Hahn says the cross-Center Coronavirus Treatment Acceleration Program (CTAP), involving CBER and CDER staff, has reviewed more than 230 trials for potential Covid-19 treatment therapies. In a CTAP update report, Hahn also says there now are more than 510 Covid drug developmemt programs in planning stages.

CTAP was created in the early days of the pandemic, he says, “to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease.”

He says CTAP enables CBER and CDER to leverage cross-agency scientific resources and expertise to bear on Covid-19 therapeutic development and review.

In what could be an effort to better communicate FDA’s role to a seemingly confused and questioning public, Hahn writes that while FDA is part of a whole of government approach to Covid-19, CTAP is a distinct component of the effort that focuses specifically on therapeutics, not vaccines or devices.

Another major initiative of the U.S. government, Operation Warp Speed (OWS) funds and rapidly develops or co-develops vaccines, therapeutics, and diagnostics, while FDA, through CTAP, regulates therapeutic development, he writes. There is a clear delineation between OWS executive actions and FDA regulatory decision-making, Hahn says.

FDA established a special e-mail inbox for potential therapeutic developers that Hahn says helps researchers and developers get directed to the right person on the first try and also enables the agency to track inquiries. Each inquiry is reviewed by a triage team of experienced clinical reviewers, other scientific reviewers, policy experts, and regulatory project management staff. Their goal, the update says, is to acknowledge receipt within 24 hours.

“These staff help those with proposals for potential Covid-19 therapeutics identify and add any information necessary to ensure that the proposal is complete enough for productive discussion,” Hahn says. “Then the team sends the proposal with a brief synopsis to the right organizational unit within FDA for review by disease area experts.”

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

Read more

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