Drugs

CDER Ramps Up Enforcement of ClinicalTrials.gov Compliance

CDER has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registration and the results reporting requirements. Speaking during a virtual Food and Drug Law Institute conference 12/9, CDER Office of Compliance director Donald Ashley said ClinicalTrials.gov compliance continues to be an area of “focused attention for CDER” and 2021 saw the first three notices of noncompliance issued to alleged violators.

Last year, CDER began to increase “pre-notice of nonompliance letters,” which are not official enforcement actions and the letters are not made public. In a previous presentation, Ashley noted that if FDA determines that a responsible party has not come into compliance after receiving a pre-notice letter, CDER will then move to actually issue a notice of noncompliance, which is a public notice, and if the responsible party still doesn't come into compliance FDA may then consider pursuing civil monetary penalties. “So we're identifying violations through evidence collected during inspections conducted as part of FDA bioresearch monitoring program, and also identifying violations based on an evaluation of complaints that we receive,” he said at the time. “And we're also developing our own risk-based surveillance methodologies to identify potential non compliance.”

Ashley said the first letter of noncompliance was issued to Acceleron Pharma for failing to submit required summary results information to ClinicalTrials.gov. The letter gave the firm 30 days in which to submit the information from a trial that evaluated the safety and effectiveness of dalantercept in combination with axitinib (Pfizer’s Inlyta) in patients with advanced renal cell carcinoma. Two other letters have also been issued to Accuitis Inc. and sponsor/investigator Andrey Petrikovets. The letters and details on the noncompliance can be seen here.

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