Drugs

‘Procedural Deficiency’ in Lupin Tarapur Inspection

An FDA 8/27-8/31 inspection at the Lupin Tarapur, India, drug manufacturing facility closed with one inspection observation that the company termed a “procedural deficiency” in a statement to news media in India. The statement says the inspection focused on cGMP compliance and also on the safety of Lupin’s valsartan, losartan, and irbesartan active pharmaceutical ingredients (API) in light of a regulatory alert on the NDMA impurity in valsartan API supplied by some companies. “During the inspection, FDA concluded that the manufacturing processes of Lupin ‘sartans’ are safe with no chance of presence of the NDMA impurity in the APIs,” the statement says.

An 11/2017 FDA Warning Letter cited cGMP issues at Lupin’s Goa and Indore manufacturing facilities.

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