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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
With the price of opioid rescue drug naloxone nearly quadrupling in Baltimore last year, Baltimore City Health Commissioner Leana Wen called for a federal investigation into the drug, which holds a spot on the World Health Organization’s List of Essential Medicines. Read More
The Secretary’s Advisory Committee on Human Research Protections is asking for more data on how proposed changes to the Common Rule requiring the use of a single IRB across a multisite trial could affect workflow. Read More
A recent report suggests the advisory committees that the FDA relies upon to ensure medical products are safe and effective can be wildly inconsistent in their recommended approval rates. 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in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance.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
The FDA is receiving criticism for again delaying a final rule on generic labeling, with some accusing the agency of putting patients at risk. Read More