Drugs

Comments on Visible Particulate Inspection Guidance

AstraZeneca says it “welcomes FDA’s provision of clear guidance on the inspection of injectable products for visible particulates.” The company’s response to an agency draft guidance on the topic also includes line-by-line specific comments.

Boehringer Ingelheim’s response says the intent and overall goal of the draft is well understood and the value of such a document is acknowledged and appreciated. “However,” it says, “clearer guidance and clarification is required at some passages to avoid ambiguity or misinterpretation.” The company includes specific comments on areas it believes need more work.

The International Society for Pharmaceutical Engineering says the guidance “includes more topics than the title suggests.” While the title refers only to visual inspection, it says, the content comprises additional issues such as manufacturing and product lifecycle considerations and investigations. “We suggest improving the title to reflect the full content of the document (for example, reference to pharmacopeia, product design, and good manufacturing practice topics such as facilities design, equipment design, etc,” ISPE says. It also includes specific comments.

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