Drugs

Comments on FDA Immunogenicity Information Guidance

Commenting on an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format, AstraZeneca says some clarification is needed on methodology adequacy, data sufficiency, and definitions of anti-drug antibody incidence versus prevalence. The company letter also says the change to having a dedicated Immunogenicity section under Clinical Pharmacology is a “much-needed improvement to consistently report immunogenicity information as part of Prescribing Information.”

Janssen says the draft “provides a helpful framework to ensure the inclusion of clinically relevant immunogenicity information in product labeling. Presenting immunogenicity information in a consistent manner will enable healthcare practitioners to access the relevant data on immunogenicity and any clinically relevant effects on pharmacokinetics, safety, or effectiveness to inform their prescribing decisions.”

Both responses also contain line-by-line specific comments.

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