Drugs

FDA to Change Some Trial Registration Enforcement

FDA has granted a Universities Allied for Essential Medicines 2/27/23 petition request that the agency consider a different enforcement framework in its approach to registration of applicable clinical trials at ClinicalTrials.gov. “We believe that … the agency’s current enforcement policy … has been effective,” the FDA response says. “However, FDA grants the petitioners’ request to consider petitioners’ enforcement framework to the extent FDA decides in the future to revise the civil money penalties guidance.”

The agency also granted the petition’s request to create a public dashboard of its pre-notice letters on potential noncompliance with the registration and results information submission requirements for ClinicalTrials.gov. The letter says all previously issued pre-notice letters were posted 12/4/2023, and the dashboard will be updated quarterly.

The petition had asked that FDA:

increase enforcement of the ClinicalTrials.gov requirements by issuing more pre-notices and notices of noncompliance and imposing civil money penalties when appropriate;
order the drafting and issuance of a new guidance explaining how FDA will focus its enforcement efforts; and
create a public dashboard of pre-notices sent by FDA.

In addition to granting the two provisions above, FDA denied:

the petition request to commit to sending a minimum of 250 pre-notices annually;
the request that the agency “be more stringent about issuing notices of noncompliance to those responsible parties who fail to take actions in response to pre-notice letters”;
the request that FDA take enforcement action, because such a decision rests in agency absolute discretion; and
the request to rescind the civil money penalties guidance.

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