The Food and Drug Administration on Monday issued new warning labeling guidance for medicines containing acetaminophen, according to a blog posted by the Regulatory Affairs Professionals Society. "The guidance ... helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirheumatic OTC drugs would be able to change liver warnings when the product's directions for use result in a maximum daily dose of acetaminophen that is less than 4,000 mg for adults," wrote Zachary Brennan. (RAPS)
With the 17th Annual NACDS Foundation Dinner rapidly approaching, the publicity surrounding the 2015 Get Smart About Antibiotics Week provides a timely demonstration of the public health relevance that the NACDS Foundation's benefactors will support on Dec. 3.
CQ Roll Call profiled NACDS’ VP government affairs in a piece ahead of the Nov. 16 ceremony for the Professional Women in Advocacy Conference’s Excellence in Advocacy award, for which Kelly is a finalist.
Valeant Pharmaceuticals’ decision to raise the prices on a handful of drugs it has acquired over the past few years has led federal lawmakers and the Department of Justice to demand that the company explain its pricing policy.
As 2015 draws to a close, the year is on track to be one in which the value of the branded drugs losing their patent protection approaches an all-time high. The dozens of drugs that will have lost their patent protection this year are estimated to have global sales of $44 billion a year — the highest total since $53 billion worth of medications went off patent in 2012.
Rapidly rising prices for many generics, regulations that could restrict patients’ access to these medications, a Food and Drug Administration backlog in getting new drugs approved and market consolidation that is reducing competition are all making some wonder how much longer generics will continue to be affordable.