Drugs

Suggestions for ‘Substantial Evidence’ Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates that FDA used a new draft guidance on demonstrating substantial evidence of effectiveness for human drug and biological products to complement and expand on an existing 1998 guidance to address new, innovative drug development approaches. In a comment letter, the trade group recommends that the agency clarify how the two guidances relate to each other. It also suggests that FDA re-issue a new draft guidance that consolidates still-relevant content from the 1998 guidance with the new content introduced in the 2019 guidance to ensure clarity for sponsors, regulators, and other stakeholders. “Consolidating the 1998 and 2019 guidance also would allow FDA to update the examples in the 1998 guidance with more recent examples,” the comment says.

PhRMA includes additional general and specific comments and recommendations.

The American Society of Gene and Cell Therapy says it commends FDA attention within the draft guidance to evidence relating to trial designs, trial endpoints, and statistical methodology that were not addressed in the 1998 guidance. “We strongly agree that expedient delivery of safe and efficacious gene therapy to patients with no other options is of utmost importance, and we appreciate FDA efforts toward this end through clarification on the evidence required for these therapies,” the letter says.

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