Drugs

Guidance on Aluminum Content in Parenteral Drugs

FDA has issued a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document is intended to clarify key factors in calculating the aluminum content to ensure that the total aluminum exposure (TAE) from parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides recommendations on aluminum concentration limits (ACLs) for small volume parenteral drug products.

According to the guidance, due to the potential health risks from long-term exposure to aluminum, FDA intends to have sponsors “limit the individual aluminum exposure in each drug product to ensure that the TAE from all components of PN in an admixture does not exceed 4 to 5 micrograms/kilogram/day40 (mcg/kg/day) of aluminum, a level above which toxicity may occur (as described in 21 CFR41 201.323(e)). To achieve these aims, FDA recommends sponsors and applicants develop mitigation and control strategies to reduce aluminum contamination in their drug products through formulation design optimization, raw material and component control, manufacturing equipment and process optimization, and selection of appropriate container and closure system(s).”

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