Nine years ago, Congress passed an important piece of legislation requiring unique medical device identifying numbers on all medical devices. The law requires manufacturers to label each medical device,...
The U.S. Food and Drug Administration usually spends its time reviewing medical devices or inspecting food facilities, but lately the agency has taken on the cosmetic industry with more...
Because cancer is one of the leading causes of death in adults, the market for cancer drugs has welcomed new treatments with open arms; but are new treatments all...
Pharmaceutical and medical device companies have been complaining for years that the FDA approval process is long and expensive, stifling medical innovation. In response, legislators have included new language...
The FDA’s recent findings over the popular drug Chantix have some painfully obvious advice for doctors: accepting money and gifts from pharmaceutical companies could cloud judgment when prescribing medication....
People will go to extravagant lengths for weight loss, but the newest treatment for obesity has actually earned FDA approval. Obalon Therapeutics, Inc. is offering a novel, nonsurgical, and...
The U.S. Food and Drug Administration (FDA) released a draft guidance addressing the program that approves third parties to review premarket notification (510(k)) submissions for medical devices. The guidance...
Ovarian cancer is one of the most aggressive forms of cancer for women, but now the U.S. Food and Drug Administration (FDA) is warning women that some screening tests...
The U.S. Food and Drug Administration is supposed to be the watchdog agency overseeing medical device and drug companies and ensuring they are following regulations, but it appears the...
The U.S. Food and Drug Administration (FDA) announced it will hold a public meeting with the healthcare industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, healthcare...