Drugs

3 More Comments on RWD Draft Guidance

Regeneron says an FDA draft guidance on considerations for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making for drug and biological products should acknowledge the rapidly advancing state of science about RWE. “This guidance should make clear that this is a dynamic topic and highlight the agency’s flexibility and receptivity in engaging with sponsors to advise on and explore approaches, concerns, and considerations specific to individual drug development programs, the company letter says.

Regeneron also says that in its experience with RWD, many of the recommendations outlined in the document around data collection, curation, management, and storage are generally outside of the sponsor’s control because they concern processes that may be considered proprietary for the companies that curate the data and/or may not be readily available to sponsors. The company also provided line-by-line comments.

Gilead said the agency’s RWE framework and this draft guidance “will enhance data collection, analysis, stability, and integrity, which are essential to FDA’s standards for substantial evidence requirements.” The company called on the agency to leverage applicable fit-for-purpose data ecosystems containing data validation tools that could easily be adapted to RWE.

Boehringer Ingelheim submitted 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