Biologics

Covid-19 Treatment, Prevention Products Guidance

FDA has published a final guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in developing such products. The document describes the agency’s current recommendations for Phase 2 and 3 trials, with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations.

“There may be some additional considerations for some biological products (e.g., cellular and gene therapies and blood products),” the guidance says, “so FDA encourages sponsors to reach out to the applicable review division as appropriate.”

FDA says developing drugs to treat so-called Long Covid-19, preventive vaccines, and convalescent plasma are all outside the scope of this guidance.

The guidance is being implemented without prior public comment as the agency says it has determined that prior public participation is not feasible or appropriate. Although the guidance is being implemented immediately, FDA says public comments still will be received following agency good guidance practices.

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

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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