Drugs

Natco Pharma Inspection Report

FDA has released the FDA-483 issued at the conclusion of a 1/16-1/24 inspection at Natco Pharma, Telangana, India. Specific inspection observations included:

failing to fully follow responsibilities and procedures applicable to the quality control unit;
failing to follow the written stability testing program;
failing to have laboratory controls include establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to submit a Field Alert Report within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article;
failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.

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