FDA Policy/General

Former Able Labs Quality Manager Debarred

Federal Register notice: FDA has denied a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases its order on a finding that Patel was convicted of a conspiracy to commit a felony under federal law for conduct relating to the regulation of a drug product. The notice says that in 2007, Patel pled guilty to one count of conspiracy to distribute misbranded and adulterated drugs. Subsequently, in 2010 the New Jersey District Court sentenced Patel to two years of probation. The conviction was related to his employment at Able Laboratories, Inc. (Able), where he was a quality control manager. According to the guilty plea, Patel supervised the falsification and manipulation of assay test results for atenolol, a prescription medication for cardiac conditions, and he directed a subordinate chemist to falsify and manipulate dissolution test results for methylphenidate hydrochloride extended-release tablets, a prescription medication for attention deficit and hyperactivity disorder. To view the notice, click here.

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