Drugs

Lupin Limited ’483 Released

FDA has published the FDA-483 issued following a 6/12-6/16 inspection at Lupin Limited, Madhya Pradesh, India. Observations shown in the form were:

failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
failing to establish control procedures that monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
failing to take representative samples of in-process materials for determination of conformance to specifications;
failing to maintain adequate acceptance criteria for the sampling and testing conducted by the quality control unit to assure that batches of drug products meet each appropriate specification as a condition for their approval and release; and
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.

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