Drugs

Gottlieb Unveils New Drug Evaluation Science Office

FDA commissioner Scott Gottlieb unveiled agency plans 1/8 to create a new Office of Drug Evaluation Science to modernize the drug review process. “We envision a world where we’re going to move toward a much more structured review process where the data will be available in a cloud-based environment,” Gottlieb said during the 37th Annual JP Morgan Healthcare Conference in San Francisco. Eventually, agency reviewers will collect the data from the cloud and do a more structured analysis, according to a report by the American Journal of Managed Care.

The new office will begin this year with a structured review of safety data. It will also evaluate elements that have been playing an increasing role in the drug review process, including biomarker use and validation, bioinformatics, and patient-reported outcomes. It will focus resources on developing tools that sponsors can use to develop drugs, and tools for FDA to improve its review activities.

The office will aim to create tools intended to make it less expensive and risky to create new drugs, Gottlieb told BioCentury. “The whole reason the cost of drug development is high is that the science of prediction is costly and uncertain. We think these tools can help us better define the science of prediction.” The office will be housed in CDER’s Office of New Drugs, with an initial staff of about 51. It will contain divisions focused on clinical outcome assessments, biomedical informatics and safety analytics, and biomarker development.

The increased focus on biomarkers reflects scientific advances, Gottlieb told BioCentury. “Finally, the science is becoming more rigorous, so we have an opportunity to understand biomarkers much better and their predictive value, given the better scientific tools we have now. This creates an opportunity for a much more structured approach to evaluating biomarkers with a new and more rigorous process.”

During his address, Gottlieb also touched on future developments for biosimilars, such as a finalized interchangeability guidance, the ability to carve out indications in biosimilar submission, and an updated Purple Book. He also said FDA is looking at ways to allow biosimilar developers to source products from outside the U.S. for required biosimilar studies included in the regulatory submission.

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