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The FDA plans to begin sharing more quality inspection data with its European counterparts so that regulators on both sides of the Atlantic can direct their resources on the riskiest companies. Read More
The FDA has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
British health-payment authorities reversed course last week and cleared the way for the use of Astellas Pharma’s advanced prostate cancer drug Xtandi in men who already had been treated with Johnson & Johnson’s competitor product Zytiga. Read More
Sun Pharma is in the midst of another quality problem, this time involving a massive recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Teva is making a last-second attempt to delay generic versions of its multiple sclerosis drug Copaxone from hitting the market, asking a federal court to require ANDA seekers to submit more data. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More