Drugs

FDA Warns India’s Ipca Labs Over GMPs at 3 Plants

FDA has issued Indian drug maker Ipca Laboratories a Warning Letter over GMP issues at three of its drug manufacturing plants — Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa). The facilities were inspected in 2014 and 2015, and they have been under an import alert since early last year. Previously, the company reported that it had voluntarily suspended shipments of its active pharmaceutical ingredients (API) and finished products from these plants until the inspectional observations are resolved.

“The company has responded to the U.S. FDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner,” Ipca said in a note to investors. “Since the inspection, the company has regularly communicated with U.S. FDA with periodic updates on remedial measures undertaken.”

When FDA issued the import alert 1/22/2015, it was reported that GMP and data integrity issues concerned the firm’s Ratlam API facility and were related to the company’s laboratory practices and staff training. These problems cascaded down to the two other facilities (Piparia and Indore) because they use the APls in their manufacturing, the firm said at the time.

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