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The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Read More
Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
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