Biologics

FDA, EMA Chair Regulators’ Covid-19 Vaccine Meeting

CBER director Peter Marks says that FDA and the European Medicines Agency jointly chaired a 3/18 meeting of global regulators to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines for use in the Covid-19 pandemic. An FDA statement says the meeting's purpose was to promote, to the extent possible, regulatory convergence to streamline SARS-CoV-2 vaccine development.

FDA’s Europe Office organized the audio/video conference that was conducted under the auspices of the International Coalition of Medicines Regulatory Authorities and brought together more than 60 experts representing 25 agencies and 17 countries, along with the World Health Organization, the statement says.

Regulators reportedly focused on the preclinical data needed to demonstrate safety and thus support proceeding to first-in-human clinical trials. The discussions included the need for data evaluating the theoretical risk for vaccine-induced disease enhancement. They acknowledged the urgency of proceeding to human clinical trials with SARS-CoV-2 candidate vaccines in light of the current Covid-19 pandemic and stressed the importance of preclinical and clinical risk mitigation strategies so that those enrolled in trials are not exposed to unreasonable risk, FDA 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