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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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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
As Merck looks to expand the indications of its lipid-reducing drug Vytorin to include cardiovascular outcomes, the FDA is asking whether trial findings describe the full picture well enough to substantiate benefit. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
With such a strong unmet need in severe asthma patients and convincing evidence of improvement in this population, Teva Pharmaceuticals’ candidate reslizumab warrants approval, FDA advisors said Wednesday. Read More
Physician groups frustrated with federal plans to pair different biosimilar drugs together for billing and reimbursement purposes are turning to Congress for help. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Wednesday. Read More