Drugs

FDA Urged to Do More for Patient-Focused Drug Development

A report on FDA’s use of patient-focused drug development (PFDD) in regulatory decision-making calls on the agency to continue to develop and update PFDD guidance and to consider expanding its compendium of clinical outcome assessments (COAs) to delineate not-yet-accepted and accepted patient experience PFDD tools and COAs, with information about when they are or are not acceptable and why. The report also says agency reviewers should be asked to include the topic of patient experience data in meetings with sponsors and applicants.

As required by the CURES Act, FDA evaluated its use of PFDD in regulatory decision-making, in particular concerning the review of patient experience data and information on PFDD tools as part of applications approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act. The evaluation report was prepared by Eastern Research Group and answers these assessment questions:

how FDA uses patient experience data in regulatory decision-making;
how FDA staff, applicants, and other stakeholders describe the agency’s use of patient experience data in regulatory decision-making; and
what good practices and opportunities for improvement exist for use of patient experience data in regulatory decision-making.

The paper has nine findings and recommendations.

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