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The FDA has put the brakes on approving Opko’s secondary hyperparathyroidism candidate Rayaldee, citing third-party manufacturer deficiencies that resulted in a Form 483. Read More
The FDA has sped up its review time of new drugs markedly in the last five years, decreasing its average time for a decision from 21 months to 10 months in 2015, according to a new report. Read More
French authorities are calling for the withdrawal of Anuh Pharma’s GMP certificate after an inspection turned up 24 alleged GMP deficiencies. Read More
A House committee is pressing the FDA on how it’s dealing with drug adulteration for economic reasons, citing the infamous 2008 heparin contamination scandal that killed at least 81 and infected hundreds more as a prime example. Read More
A non-profit group is pressing the National Institutes of Health to bypass the patent rights of a drugmaker in a bid to lower the drug’s price, marking at least the third time the group has attempted this. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More