Drugs

Praise for FDA Final PFDD Guidance

Genentech says an FDA draft guidance on incorporating clinical outcome assessments into endpoints for regulatory decision-making “marks a critical milestone as the final installment in FDA’s patient-focused drug development (PFDD) methodological guidance series that aims to describe a sustainable path to incorporate patient input as data in medical product development and decision-making.” The company comment letter says, however, that the guidance discussion on how the meaningfulness of treatment benefit can be evaluated using meaningful score differences or meaningful score regions is overly complex and it is unclear how the two techniques relate to meaningful within-patient change or between-group change. “We are concerned that this will introduce unnecessary confusion and differences of interpretation amongst sponsors and reviewers, and will ultimately limit the uptake of PFDD methods and deter investment, development, validation, and acceptance of clinical outcome assessment data,” the company says.

In its comment, AbbVie says it appreciates the emphasis in the guidance series on providing an evidence-based rationale for incorporating patient experience data into medical product development, as well as the approach in this guidance to allow for greater flexibility in endpoint construction and score interpretation.

EMD Serono says the final guidance could benefit from a methodological elaboration on how best to weigh and consolidate the respective contributions of patients and their caregivers on study design elements and avoid considering the patient voice out of context. It also says the guidance could benefit from clarification on whether the meaningfulness of clinical outcome assessment endpoints is only from the patient’s perspective or from additional stakeholders, such as their caregivers, as well.

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