Biologics

Cellebration Refusing to Provide Records to FDA

FDA says that despite repeated requests, Cellebration LLC, headquartered in San Juan, Puerto Rico, has failed to provide records sought by the agency since 10/18/2024. A 9/12 Warning Letter says the Cellebration Web site was reviewed by FDA, which found that the company offers cellular products derived from cord blood for use in treating or preventing various diseases or conditions.

The letter says that when FDA made its initial records request, the company asked for two successive 30-day extensions, which were granted. It says a second record request was then sent on 4/23, and Cellebration indicated it had responded several weeks earlier.

FDA says it notified Cellebration that it never received its response and asked that it be re-sent. “In response,” it says in the Warning Letter, “you stated that you were unclear about what we are seeking. On 5/21 and 5/28, we sent additional follow-up emails again asking you to provide the requested records. FDA has not received a response to its request to date, even though FDA’s request and follow-up communications sufficiently and clearly described the records sought.”

Cellebration was told to take prompt action to address the matter and to respond within 15 days or explain the reason for any further delay and provide a schedule for complying.

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