Drugs

Draft Elemental Impurities Guidance Needs Update: Glaxo

GlaxoSmithKline says that while an FDA draft guidance on elemental impurities in drug products is a “well-written and informative document” that supports a risk-based approach to controlling elemental impurities, it is not up to date with respect to two U.S. Pharmacopeia (USP) chapters. “We assume that this lack of current alignment is due to the chronology of events,” the comment letter says, “and that the revisions to USP general chapters 232 and 233 will be reflected in the final FDA guidance when it is issued.” Glaxo also says it welcomes the FDA statement in the draft that the agency anticipates that most approved products currently on the market in the U.S. do not contain elemental impurities that exceed the specifications in the relevant International Council on Harmonization (ICH) guidelines and USP chapter.

In its comment, the Generic Pharmaceutical Association (GPhA) asks for clarification on how FDA hopes or plans to align with other health authorities on the ICH document, particularly Health Canada’s requirement that finished drug product specification updates contain a statement confirming compliance with the ICH guideline. GPhA also asks for clarification if there is an expectation that drug testing be will done routinely as part of the risk assessment process. “The guidance seems to require product testing as proof/verification of elemental impurity levels evaluated as part of the risk assessment,” the letter says. “This requirement appears to be not aligned with the principles of risk assessment ICH Q9.”

In its letter, Sanofi asks for a table with implementation dates to avoid confusion with wording in a number of sections.

All three commenters also include specific line-by-line questions and recommendations.

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