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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
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
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 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
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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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
India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country. Read More
The Secretary’s Advisory Committee on Human Research Protections is asking for more data on potential workflow effects of proposed changes to the Common Rule that would require the use of one single IRB across a multi-site trial. Read More
The European Medicines Agency conducted 350 good manufacturing practices inspections in the first half of this year — roughly 50 percent more than in the same period a year ago, a new report shows. Read More
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More