Drugs

FDA Activities to Expand Real-World Evidence Use

FDA commissioner Scott Gottlieb says the agency is undertaking additional activities to advance the opportunity to use real-world data (RWD) and real-world evidence (RWE) for the benefit of patients. In a 1/28 speech to the Bipartisan Policy Center Conference, he outlined the activities as:

supporting the seamless integration of digital technologies in clinical trials;
using digital technologies to bring clinical trials to the patient, rather than always requiring the patient to travel to the investigator; and
exploring how agency medical reviewers can have more insight into how labeling changes inform provider prescribing decisions and patient outcomes.

In his remarks, Gottlieb said FDA recognizes that new approaches and new technologies can help expand the sources of evidence that can be used to make more reliable treatment decisions. He said the agency is committed to advancing ways that data leveraged from streams typically called real-world data are transformed into evidence using transparent data standards that can give all stakeholders confidence in the data’s provenance, so that more of the data can be used to generate the evidence that the agency needs to improve regulatory decision making. “Advancing RWD into regulatory quality real-world evidence is a key strategic priority for FDA,” he declared.

“RWD and RWE are already being used extensively for postmarket monitoring of the safety of products during their use in real-world settings,” Gottlieb said. “To give just a few examples, our use of RWD and RWE, derived from our Sentinel system, eliminated the need for postmarketing studies on nine potential safety issues involving five products, making our postmarket evaluation of safety timelier and more effective.”

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