Drugs

Real-World Data, Evidence Guidance Explained

CDER Office of Medical Policy health science policy analyst Lauren Milner says a new agency draft guidance on submitting documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics is needed because the availability of such data and evidence has created interest within research and medical communities to enhance clinical research and support regulatory decision-making. In an agency Webinar on the draft, Milner also said the 21^st Century Cures Act requires the agency to establish a program to evaluate potential use of RWE to (1) help support approval of new indications for approved drugs, and (2) help support or satisfy postapproval study requirements.

“CDER and CBER intend to identify and track certain types of submissions using RWE to inform FDA’s RWE program under the Cures Act and to help FDA understand the scope and use of RWE submitted to support regulatory decisions regarding safety and/or effectiveness,” Milner said. She said the agency hopes the draft guidance will help maintain a dialog and mutual learning with external stakeholders on their individual efforts in RWE.

According to Milner, the draft is intended to encourage sponsors and applicants who are using RWD to generate RWE as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. The guidance applies to submissions under INDs, NDAs, and BLAs.

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