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McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids. Read More
The high court will review Bristol-Myers Squibb’s appeal of a California Supreme Court ruling that grants the state’s courts jurisdiction to hear lawsuits filed by non-state residents. Read More
The FDA handed Chinese manufacturer Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for the broader uses of research methodologies in real-world settings, but cautioned against expectations for “quick wins” in efficiency and savings. Read More
Wockhardt is in hot water with the FDA again, receiving another warning letter for significant GMP violations regarding quality and data controls. Read More