Drugs

Suggestions for FDA Draft Guidance on Some Oncology Studies

Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends FDA for publishing a draft guidance on streamlining nonclinical safety studies for some oncology pharmaceuticals, particularly biologics and conjugated products. The association’s comment letter says issuance of the draft is a significant step toward implementing FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. PhRMA says that while it strongly supports the draft guidance, maximizing its impact will depend on (1) preserving the flexibility inherent in existing FDA and International Council for Harmonization guidances; (2) providing sufficient regulatory predictability for sponsors making early development decisions; and (3) ensuring consistent implementation across review divisions. PhRMA submits recommendations it says will support the three objectives.

The American Association for Cancer Research (AACR) says it strongly supports FDA’s efforts to modernize nonclinical safety assessment and makes recommendations in these areas it says will further strengthen the draft:

expand the discussion of weight-of-evidence assessments;
expand product-specific recommendations; and
clarify that the weight-of-evidence assessments are iterative.

“AACR applauds FDA’s continued leadership in advancing modern, science-based approaches to oncology drug development and believes this draft guidance represents an important step toward more efficient, evidence-based nonclinical safety assessment for oncology therapeutics,” the letter concludes.

The Critical Path Institute encourages FDA to continue fostering flexibility in the application of the guidance across therapeutic areas and product types while recognizing the importance of context-specific scientific justification.

Finally, the American Association of Pharmaceutical Scientists provides specific line-by-line 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