We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A Michigan clinic manager pleaded guilty to a scheme to unnecessarily prescribe controlled substances that lost Medicare $131 million, and Attorney General Jeff Sessions called the plea the latest victory in Justice Department efforts against those exploiting the opioid addiction epidemic. Read More
Federal right-to-try legislation passed in the Senate and now awaiting a vote in the House would only minimally benefit patient access to investigational drugs and would delay the FDA’s approval process for new drugs, according to bioethicists at the University of Pennsylvania’s Department of Medical Ethics. Read More
The lawsuit alleges the drugmakers used deceptive marketing to convince doctors and patients of the value of opioids in treating chronic pain. Read More
The new guidance distinguishes between trials involving DMARD-naïve patients, those who have had an inadequate response to one prior DMARD treatment and those who have had an inadequate response to multiple treatments. Read More
The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility. Read More
The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product. Read More
The Federal Trade Commission took CellMark Biopharma to federal court for falsely advertising two of its supplements as “clinically proven” to treat cancer and cancer treatment side effects. Read More
A new CDER-funded study says the FDA is not taking full advantage of social media to communicate drug safety information — and should, for example, be making more use of Twitter in its campaigns. Read More