Drugs

Biocon FDA-483 Released

FDA has released the FDA-483 issued following a 2/6-2/15 inspection at Biocon Sdn Bhd, a Johor, Malaysia, sterile drug manufacturer. The inspection observations were:

failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing to thoroughly review any unexplained discrepancy to ensure that drug products conform to predetermined quality attributes;
failing of an unexplained discrepancy to extend to other batches of the same drug product or other drug products that may be associated with the specific failure or discrepancy;
failing to follow written production and process control procedures in execution of production and process control functions;
failing of laboratory controls to include establishment of scientifically sound and appropriate test procedures designed to ensure that drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to have sufficient procedures for the cleaning and maintenance of equipment regarding inspection of the equipment for cleanliness immediately before use.

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