Biologics

Clinical Trials Penalties Guidance

FDA has issued a draft guidance describing its current thinking on civil money penalties relating to requirements to submit registration and/or results information to ClinicalTrials.gov and/or certain certifications to FDA. The draft addresses these questions:

how CBER, CDER, and CDRH intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov databank or submitted false or misleading information to the databank, or whether submitters have failed to submit to FDA the certification required by law or knowingly submitted a false certification to FDA;
the circumstances under which a Center decides to seek civil money penalties against a responsible party or submitter;
the procedures that apply when a Center seeks civil money penalties; and
the civil money penalty amounts that may be assessed for (1) failing to submit required clinical trial registration and/or results information to the databank; (2) submitting false or misleading information; (3) failing to submit required certification to FDA; or (4) knowingly submitting a false certification to FDA.

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