Biologics

FDA Orders Fertility Clinic to ‘Cease Manufacturing’

FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute in San Juan, Puerto Rico, and its medical director/owner to immediately cease manufacturing due to significant violations of FDA regulations. An agency statement says an inspection and record review revealed significant violations of regulations on donor eligibility determinations, including donor screening and testing. “The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis,” it says.

Under the order, the clinic must immediately cease all manufacturing of HCT/Ps (human cells, tissues, or cellular or tissue-based products) from directed or anonymous reproductive tissue donors, which includes any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and the screening or testing of cell or tissue donors. The order also requires the clinic to continue to store all HCT/Ps subject to the order, which are in their possession or received after the 11/25 date of the order. It cannot resume operations until it complies with agency regulations and receives agency written authorization.

FDA says it has offered the clinic an opportunity for a regulatory hearing and that the clinic has five days to request a hearing. It says it is not aware of any reports of transmission of communicable diseases from patients at the clinic.

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