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The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments and other methods to aid regulatory review. Read More
The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first time the agency has taken steps to remove a currently marketed opioid from sale. Read More
The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs. Read More
The House Energy and Commerce Committee voted 54-0 on Wednesday to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate, more on the rising cost of prescription drugs than on the fee programs at the heart of the bill. Read More