Drugs

ICH Approves 2 Guidances

The International Council for Harmonization (ICH) says it has adopted a new guidance relating to clinical trials in children that complements one from 2000. The new document, it says in a news release, addresses new scientific and technical knowledge advances in pediatric drug development and updates certain aspects of the earlier guideline. Included are guidance on ethical considerations, age, classifications, and subgroups for children, pediatric formulations, and guidance on extrapolation in pediatric drug development and trial designs.

A second new harmonized guidance addresses collection of genomic information for use in evaluating efficacy and safety of a drug for regulatory approval. ICH says the guideline clarifies that genomic data should be collected in clinical trials and other studies in accordance with certain methodologies during drug development and throughout the product life cycle. The guideline also covers the storage and retention of genomic samples.

Also approved was a question-and-answer document to provide additional clarification and promote convergence on considerations for selection and justification of starting materials, and on information that should be provided in marketing authorization applications and/or master files. ICH says this document’s focus is on chemical entity drug substances.

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