Biologics

Regenerative Stem Cell Institute Unapproved Cell Products

The CBER Office of Compliance and Biologics Quality says its review of a Web site and social media sites maintained by the Regenerative Stem Cell Institute, Elgin, IL, determined that the firm markets cellular products derived from adipose tissue to treat diseases or conditions such as cerebral palsy, asthma, emphysema, chronic obstructive pulmonary disease, and rheumatoid arthritis. A 4/6 letter to the institute says the firm’s products are regulated as drugs and biologics requiring a valid BLA or IND.

“You claim that your cellular products are offered ‘under an IRB approved research protocol,’” the letter says. “Before initiating clinical trials with an investigational drug or biological product, a sponsor must have both an IND in effect and an approval from an institutional review board (IRB). IRB approval is required in addition to, not in lieu of, obtaining an effective IND from FDA for the study of the investigational drug or biological product.”

The institute was told to respond to CBER and to present its reasoning if it does not believe there is a basis for the regulatory issues raised in the letter.

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