Drugs

Finalize Patient Data Collection Guidance: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on collecting comprehensive and representative patient input issued under the PDUFA 6 goals letter will help “advance science-based approaches to collecting, analyzing, interpreting, and incorporating robust and meaningful patient data into the drug development and review process.” The association recommends that the agency finalize the draft in a timely manner to help sponsors and other stakeholders understand sampling methods for collecting patient experience data that is representative of the intended population.”

It also notes in a comment letter that some technical topics specifically related to drug development are not fully addressed and should be expanded upon to provide further clarity for sponsors. PhRMA says it may be helpful for FDA to develop a follow-up guidance or question-and-answer document specifically for sponsors to provide more in-depth guidance and specific details on how patient experience data should be incorporated into drug development, regulatory review, and product labeling.

PhRMA’s letter includes 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