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Despite a vast, “herculean feat” to obtain clinical trial data, the effect of Merck’s lipid-lowering Vytorin on cardiovascular health was just too small — with worrying holes in data that could hinder any proof of clinical meaningfulness, FDA advisors said. Read More
Following congressional outcry, an NIH task force issued findings that show underlying problems with its now-shuttered drug compounding facilities were “widespread and longstanding,” but did not cause any direct harm to patients. Read More
Are pharma companies getting what they pay for in terms of R&D spending? According to a new report from the Deloitte Center for Health Solutions, the answer is no. 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
Since January, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More
The FDA has hit Life Support Development, a dietary supplement manufacturer and distributor, with a warning letter because its purported “hangover relief” product is considered an unapproved new drug. 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
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