Drugs

Elemental Impurities Guidance Published

FDA has published an International Conference on Harmonization (ICH) guidance, Q3D(R1) Elemental Impurities, addressing (1) the evaluation of toxicity data for potential elemental impurities; (2) the establishment of a permitted daily exposure (PDE) for each element of toxicological concern, and (3) the application of a risk-based approach to control elemental impurities in drug products. The document says that because elemental impurities do not provide any therapeutic benefit to a patient, their levels in a drug product should be controlled within acceptable limits.

Applicants are not expected to tighten the limits based on process capability, FDA says, provided that the elemental impurities in drug products do not exceed the PDEs.

The guidance presents a process to assess and control elemental impurities in the drug product using the risk management principles described in another ICH guidance. “This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product,” it says.

The contents include Introduction, Scope, Safety Assessment of Potential Elemental Impurities, Element Classification, Risk Assessment and Control of Elemental Impurities, Glossary, References, and four appendices.

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

Read more

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