Biologics

‘Off-Label’ Communications Q&A Guide

FDA has approved a guidance, Communications from Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers, to reassure firms that if they provide communications that are consistent with the guidance’s recommendations, the agency will not consider the dissemination of such communication standing alone as evidence of a new intended use for the product. The document also says FDA does not expect a firm to submit such a communication to it at the time the communication is initially shared with healthcare providers (HCPs).

The enforcement approach outlined in the guidance, FDA says, has as a key tenet that to promote the public health, any individual firm-initiated communication of scientific information about unapproved uses of the firm’s approved/cleared medical products should be truthful and non-misleading and should provide and appropriately present all information necessary for HCPs to understand and evaluate the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved uses in the specific communication. It says the guidance recommendations are consistent with these principles.

The guidance specifies the types of source materials that companies may use for their communications under the enforcement policy.

FDA says that in developing the guidance it considered feedback from interested parties, including comments received on a revised draft guidance from 2023. This guidance finalizes the 2023 draft, it says.

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