Biologics

FDA Updates Covid Vaccine EUA Guidance

FDA has issued an immediately effective update to its 5/2021 guidance Emergency Use Authorization for Vaccines to Prevent Covid-19. The document provides the agency’s current thinking on the data and information needed to support the issuance of an emergency use authorization for an investigational vaccine to prevent Covid-19.

Included are recommendations on chemistry, manufacturing, and controls; nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. The guidance also has recommendations regarding key information and data that should be submitted to a relevant IND or cross-referenced master file before submission of an EUA request to facilitate FDA’s complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee.

The guidance also discusses FDA’s current thinking about the circumstances under which the issuance of an EUA for a Covid-19 vaccine would be appropriate.

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