FDA

FDA push for volunteer follow-ups in clinical trials

The Administration says they want at least 2 months of data

Image: CNN (CNN)— The US Food and Drug Administration made clear Tuesday it will want to see two months of follow-up data after volunteers get their second dose of vaccine as part of clinical trials testing potential coronavirus vaccines. That would make it difficult, if not impossible, for any vaccine maker to apply for emergency use authorization by Election Day,…

FDA Approves First Dissolving Stent for US Patients

A medical implant that slowly dissolves into the body could be the answer to long-standing safety concerns with devices used to treat clogged arteries. But not so fast, say experts. Abbott Laboratories’ newly-approved Absorb stent comes with one important caveat: it hasn’t yet been shown to be safer than older metal implants. The Food and Drug Administration approved the device…

Don’t Eat Raw Cookie Dough, FDA Warns After E. Coli Outbreak

Cookie dough may be tempting to taste before it’s been baked, but the U.S. Food and Drug Administration is warning people to resist that temptation due to concerns that the dough could be contaminated with E. coli bacteria. Dozens of people have been sickened due to an outbreak of Shiga toxin-producing E. coli O121 linked to flour, prompting the FDA…