Drugs

More Pediatric Oncology Guidance Info Sought

Pharmaceutical Research and Manufacturers of America (PhRMA) says it has identified areas in an FDA draft question-and-answer guidance on pediatric study plans for oncology drugs before full implementation of section 504 of the FDA Reauthorization Act (FDARA) that would benefit from further discussion, confirmation, clarification, and/or revision in the final guidance. The association comment letter lists the areas as:

revise the draft guidance to reflect that FDARA contemplates only one molecularly targeted pediatric cancer investigation per affected application;
clarify the FDA process and timeline for determining whether available information, including any information that a sponsor chooses to submit, warrants a substantial relevance determination;
clarify that a drug candidate must be “directed at” a molecular target that FDA determined to be substantially relevant to the growth or progression of a pediatric cancer for the new investigation requirement to apply;
clarify question and answer number 4 of the draft guidance on cross-labeled drug combination regimens; and
clarify the relationship between the Pediatric Research Equity Act, as amended by FDARA, and the Best Pharmaceuticals for Children Act.

PhRMA also says it encourages FDA to exercise regulatory flexibility for new applications that are subject to the new investigation requirement and submitted on or shortly after the statutory implementation date of 8/18.

In its letter, the Biotechnology Innovation Organization (BIO) says it is unclear whether FDA plans to develop a final version of the guidance given the coming 8/18 implementation date. The association said it sees value in finalizing the guidance and making it available even after 8/18 and asks that FDA update the guidance based on stakeholder feedback. BIO also cites two areas that FDA may consider including in an updated version of the guidance that would make it a more helpful resource for drug developers who are more familiar with the new requirements.

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