Drugs

FDA Proposes Banning 3 Bulk Drugs from Compounding

FDA is proposing to ban three bulk drug substances — bumetanide, nicardipine hydrochloride, and vasopressin — from its list of bulk drug substances (active pharmaceutical ingredients) that outsourcing facilities may use in compounding. This is the first time that FDA has issued a proposal regarding whether to include bulk drug substances to its bulk drugs listing. “Our preliminary assessment is that the FDA-approved drug products containing these substances can either be used or adapted to treat patients instead of compounding new drugs from bulk drug substances as proposed by the nominations,” FDA commissioner Scott Gottlieb is quoted in a release as saying. “So, at this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances. Consistent with the DQSA ( Drug Quality and Security Act), we’re issuing a Federal Register notice outlining our proposal and seeking comments from the public before making a final decision. As we’ve said in guidance, once we make a final decision, the interim enforcement policy currently in place will no longer apply to these 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