FDA Policy/General

Fraudulent Contract Research Org. Leads to Debarment

Federal Register notice: FDA has issued an order permanently debarring Sami Anwar from providing services related to an approved or pending drug product application. The debarment is related to his recent convictions as the owner and operator of Mid-Columbia Research LLC and Zain Research LLC, contract research organizations that oversaw and conducted clinical research trials for various drug sponsors. Court documents allege Anwar’s companies fraudulently posed as legitimate human clinical research trial sites and provided false clinical research trial data regarding drug safety and drug efficacy to dozens of drug companies. Anwar also posed as a doctor and forged the signatures of the doctors he employed. In addition, Anwar had his employees assist in committing the fraud by: (1) producing false medical records and data to admit dozens of ineligible research subjects, (2) falsifying research data vital signs, (3) stealing blood samples taken from patients without their consent, (4) directing patients to dispose of study meds and then falsely record dispensing as required by the study, (5) fraudulently obtaining opioids intended to be dispensed to study subjects, and (6) falsifying subject diaries. 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