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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
Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
Effective standard operating procedures are central to any life sciences company, but the FDA’s pharmaceutical regulations don’t mention SOPs specifically. Instead, regulations refer to “procedures” related to quality control and require them to be maintained in writing and followed. Read More
The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on. Read More
The Department of Justice, the FDA and other federal partners announced a nationwide sweep that resulted in the filing of criminal and civil cases against 89 makers of dietary supplements. Read More
The FDA has hit three more compounders — two in California and one in North Carolina — with warning letters, bringing to 25 the number of warnings issued to this industry this year. 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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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 Office of Pharmaceutical Quality is in the midst of its third pilot of integrated quality assessments, a team-based review process that will be the central tenet of OPQ’s review of drug applications. 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