Drugs

FDA Posts 483 Related to New Novo Nordisk Warning Letter

FDA has posted the Form 483 behind a 3/5 Warning Letter (see story) to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting requirements.

According to an FDA Form 483 issued 2/7, investigators found that the company failed to submit more than 300 required “15-day alert” reports for serious and unexpected adverse drug experiences and submitted more than 700 others late. Federal regulations require drugmakers to report such events to the agency within 15 calendar days of first receiving the information.

In addition to reporting delays, FDA investigators said the company did not adequately investigate certain post-marketing adverse events, including cases involving the diabetes drug Ozempic. In some instances, follow-up attempts with reporters were not conducted as required under the company’s procedures, including reports involving suicide, depression and deaths.

Investigators additionally raised concerns about company procedures governing adverse event monitoring and reporting. One standard operating procedure limited follow-up with reporters when patient consent had not been obtained and the reporter was not a healthcare professional, which investigators said could hinder investigations of serious events. The procedure also allowed “non-case” reports to be rejected from the safety database without clearly defining the term.

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