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British authorities are ordering an Indian manufacturer to recall batches of progesterone injections after an inspection turned up one critical GMP violation and three major ones at one of its facilities. Read More
Valeant will pony up at least $54 million to settle Justice Department allegations that one of its subsidiaries paid kickbacks to convince physicians to prescribe more of its products. Read More
A string of proposed rules has been sitting on the FDA’s agenda for lengthy periods of time, sometimes for over a decade, and a recent accounting shows no signs of improvement. Read More
Colombia’s Ministry of Health and Social Protection announced its plans to unilaterally cut the price of Novartis’ myeloid leukemia treatment Gleevec after negotiations with the Swiss drugmaker fell through the cracks. Read More
The FDA has a slate of new recommendations companies should follow when submitting a comparability protocol assessing changes to the chemistry, manufacturing or controls of a drug or biologic after the agency has approved its production process. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More