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Following the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
In the wake of the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an update that prohibited imports from two Apotex facilities in India. Read More
On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More
While there is no set timeframe for the release of the FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More