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Just months after launching its new cholesterol combo drug Liptruzet, Merck is recalling all of the drug that hasn’t already reached customers because of concerns that defective packaging could decrease its potency. Read More
Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
Baxter is recalling two lots of Clinimix and one lot of Clinimix E premixed sterile parenteral nutrition products over complaints of particulate matter. Read More
With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
The International Society of Pharmaceutical Engineering (ISPE) is recommending six quality metrics that the FDA should consider collecting from manufacturers as part of the agency’s new quality metrics program. Read More
FDA Commissioner Margaret Hamburg has named Howard Sklamberg as the agency’s new deputy commissioner of global regulatory operations and policy. Read More
The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality. Read More
A champion in the global fight against counterfeit drugs is adding an unusual voice to growing calls for relaxing the U.S. ban on the personal importation of prescription drugs. Read More
A drugmaker convicted of bribery in China will have its products barred from being purchased by private and government-funded organizations for two years in the province where it is convicted. A second offense within five years will result in a two-year, nationwide ban. Read More