Drugs

Jubilant Generics Cited Over GMPs

FDA has issued Jubilant Generics a four-observation Form FDA-483 after inspecting the firm’s Roorkee, Uttarakhand, India facility in February.

The inspection cited the firm for not making written records for all investigations into unexplained discrepancies. FDA also took issue with the quality control unit and its responsibilities and procedures, which are not in writing and fully followed. For example, the agency says that during the walk-through inspection of your facility, FDA investigators “observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding.” These documents were prepared outside of the firm’s control and traceability system despite procedures indicating otherwise.

Additionally, the inspection found that time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. And, control procedures are not established to validate the performance of the manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product, it said.

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