Drugs

Comments on FDA ‘Medical Queries’

Eli Lilly says it appreciates FDA’s efforts to better standardize safety data and analysis. Commenting on an agency docket on Advancing Premarket Safety Analytics, Lilly asks that the agency “support efforts in ensuring the document describes a customized approach, which may bring the necessity for updating some terms with each update to MedDRA (Medical Dictionary for Regulatory Activities). “Additionally,” it says, “some preferred terms are not present in MedDRA, which may unintentionally result in coding issues by the investigators or healthcare professionals.”

The letter has specific comments for these safety topics: hypersensitivity, anaphylaxis, angioedema, malignancy, depression, self-harm, psychosis, anxiety, pancreatitis, volume depletion, decreased appetite, constipation, diarrhea, dyspepsia, hepatic failure, hepatic injury, hypotension, nausea, vomiting, and study agent abuse potential.

In its response, AbbVie provides both general and specific comments on two documents prepared by FDA for a 9/14/22 public workshop on Advancing Premarket Safety Analytics Workshop.

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