Drugs

USP Wants Reporting Threshold Comments

The United States Pharmacopoeia (USP) says it is updating organic impurities testing for articles subject to USP-NF (National Formulary) standards. A USP notice says the approach applies the International Conference on Harmonization (ICH) Q3A/B-based limits for identification and reporting of organic impurities and degradation products in drug substances and drug products. “Currently,” the notice says, “USP drug substance and drug product monographs’ impurities tests with specifications for total impurities or total degradation products will in many cases include a reporting threshold consistent with the ICH guidelines.”

However, it continues, beginning in 2016 FDA provided comments asking that thresholds not be included in drug product monographs. “Since compendial monographs are not intended to identify every impurity and degradation product,” USP says, “FDA is concerned that the inclusion of reporting thresholds could result in very toxic impurities not being identified or reported. FDA commented that reporting thresholds for drug products vary based on product-specific factors and should be addressed as an application assessment issue.”

FDA told USP it uses ICH reporting thresholds as guidelines and deviates from them as needed based on application-specific considerations.

To address the FDA recommendation, USP says it is proposing a four-part policy change pertaining to inclusion of reporting thresholds in drug substance and drug product monographs and presenting it for a 90-day comment period.

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