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The FDA has released final guidance on assessing the risks and benefits of investigational device exemption applications for human clinical studies. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
The FDA granted over 99 percent of requests for expanded access in fiscal 2016, including 100 percent of emergency IND applications and protocols. Read More
The FDA said it will delay its “intended use” rule governing when tobacco products are to be classified as drugs, devices or combination products. Read More
Four former FDA commissioners have called on Congress to abandon proposals that would allow drug imports, warning that such measures would come with substantial risks and only have a small effect on prescription drug costs and access. Read More
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release documents as part of its transparency efforts. Read More