Drugs

FDA Releases RC Outsourcing FDA-483

FDA has just released the FDA-483 issued following a 1/14-2/8/19 agency inspection at RC Outsourcing, Lowellville, OH. The eight inspection observations were:

failing to follow written production and process control procedures in the execution of production and process control functions;
failing to have a written testing program designed to assess the stability characteristics of drug products;
failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
testing and release of drug product for distribution procedures do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release;
failing to establish and document the accuracy, sensitivity, and reproducibility of test methods;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failing to conduct specific identification tests on components that have been accepted based on the supplier’s report of analysis; and
the facility compounds drugs that are essentially a copy of one or more approved drugs.

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