Drugs

FDA Sends 8-item 483 to NATCO Pharma

FDA has issued NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firm’s Telangana, India, manufacturing facility 10/18 and citing significant GMP deficiencies. For example, agency investigators said the firm’s equipment and utensils are not cleaned and maintained at appropriate intervals. The heavily redacted FDA-483 also said NATCO’s quality unit lacks “oversight pn the control and management of GMP documents that are critical in ensuring the drug products manufactured and tested at your sire are safe and effective.”

The inspection also cited the company’s lack of procedures for preventing microbiological contamination of drug products. Additionally, the investigators said NATCO failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. For example, the 483 said the firm’s laboratory investigations procedure pertaining to investigating of out-of-specification test results is deficient.

NATCO says that it is “confident” it can address all the observations within FDA’s stipulated time, and it is working closely with the agency to close the inspection’s findings as soon as possible.

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