Drugs

Consumers Getting ‘Fake’ Warning Letters: FDA

FDA says criminals are forging Warning Letters targeting individuals who try to purchase medicines online or over the telephone. An agency news release says FDA is concerned that the fake Warning Letters are linked to an international extortion scam. “FDA generally does not issue Warning Letters to individuals who purchase medicines online,” the release says.

Having cautioned consumers about the fake letters, FDA commissioner Scott Gottlieb also reminded them “of the dangers of purchasing medicines from illegal online pharmacies. These risks range from receiving unapproved and potentially counterfeit medicines to unknowingly making themselves targets to scams like these.”

The release says the agency has become aware that instead of receiving the drug products ordered on the phone or the Internet, consumers received an official-looking but fake Warning Letter either from FDA or FDA and the Federal Trade Commission. The letters claim the agency has determined that there are drug violations based on a review of the parcel and the consumers’ social media accounts.

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