Drugs

Final Rule on Bulk Drugs for Compounding

FDA has issued a final rule that adds six bulk drug substances to its bulk substances listing that can be used by compounders not registered as outsourcing facilities. It also identifies four bulk drug substances that are not allowed to be used. “Developing the bulks lists for these compounders and outsourcing facilities remains a compounding priority and we look forward to continuing this work in 2019,” FDA commissioner Scott Gottlieb says in a statement.

The rule also establishes the criteria for evaluating nominated bulk drug substances for inclusion on the bulk drugs listing. “These criteria include the physical and chemical characterization of the substance, safety issues raised by use of the substance in compounded drug products, evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance and historical use of the substance in compounded drug products,” the agency says. The final rule applies to compounding by licensed pharmacists in state-licensed pharmacies or federal facilities, and licensed physicians.

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