After stalling in the Senate for over a year, the 21st Century Cures Act was passed by Congress and signed into law by President Obama. The sweeping new legislation...
The FDA’s Office of Prescription Drug Promotion has been relatively quiet this year, but it appears the Agency is ending 2016 with a bang. The Office of Prescription Drug...
After Vincent Karst underwent open-heart surgery in early 2015, he seemed to recover well and his life slowly returned to normal. However, he slowly began to suffer from shortness...
Hospitals have a responsibility to report any adverse event related to medical devices to the U.S. Food and Drug Administration (FDA), but a recent investigation found many hospitals are...
The U.S. Food and Drug Administration (FDA) is often criticized for stifling medical innovation, but a conference that took place earlier this week has some worried the federal agency...
The laws regarding the reporting of potentially defective medical devices are spotty at best. Doctors themselves are not required to report adverse events to the FDA. Their participation is...
Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA). Doing so will help the FDA identify potentially defective...
The process of receiving approval from the U.S Food and Drug Administration (FDA) is long and expensive. Critics in the pharmaceutical industry complain the process deters advances in medicine...
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...
