Drugs

Aurobindo FDA-483 Released

FDA has published the FDA-483 issued to Aurobindo Pharma, Hyderabad, Telangana, India, following a 4/30-4/28 agency inspection. Specific violations noted on the form were:

failing to maintain in a good state of repair buildings used in the manufacturing of a drug product;
failing to include in laboratory controls establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of strength, identity, quality, and purity;
failing to have changes to written procedures drafted, reviewed, and approved by the appropriate organizational unit;
failing to thoroughly review whether or not a batch has already been distributed;
failing to have equipment used in the manufacture, processing, packing, or holding of drug products be of appropriate design to facilitate operations for its intended use;
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile.

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