Drugs

Webinar on Rx Drug Labeling Resources

FDA has announced a 1/26/2023 Webinar entitled FDA’s Labeling Resources for Human Prescription Drugs that will discuss new resources available for the pharmaceutical industry. The resources are listed on an agency-maintained Webpage and include:

Prescribing Information Resources, which includes a sample template for the prescribing information and specific resources for each section of the full prescribing information.
Patient Labeling Resources, which includes answers to questions about instructions for use, medication guides, and patient package inserts.
Carton and Container Labeling Resources that includes carton and container labeling regulatory provisions, guidances, and manuals of policies and procedures (MAPPs).
Generic Drugs – Specific Labeling Resources that covers information about requirements for generic drug labeling, recommendations on updating generic drug labeling, and generic drug labeling guidances and MAPPs.
Biological Products – Specific Labeling Resources which discusses biosimilar and interchangeable biosimilar guidances, the “deemed BLA” guidance, and nonproprietary biological product nomenclature guidances and MAPPs.
Selection of Appropriate SPL Codes for Human Prescription Drug Labeling, which includes recommendations for structured product labeling (SPL) developers in selecting the appropriate SPL codes for human prescription drug labeling.

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