Drugs

Drug Labeling Child-Resistant Packaging Statements

FDA has issued a final guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging statements in their drug product labeling. The document discusses what information should be included to support child-resistant packaging statements in labeling for NDAs, ANDAs, BLAs, and supplements to these applications.

The guidance also includes recommendations for labeling both for nonprescription drug products approved under an NDA or ANDA and those that are marketed under the over-the-counter drug review. It is intended to help ensure that such labeling is clear, useful, informative and, to the extent possible, consistent in content and format.

Included in the guidance are Introduction, Discussion, Labeling (prescription drug products and nonprescription drug products), and Process for Including Statements Regarding Child-Resistant Packaging on the Labeling (prescription and nonprescription drug products approved under an application and nonprescription drug products marketed under the OTC drug review).

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

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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