HHS Guidance To Clarify Which Adverse Events Researchers Need To Report
A final HHS guidance due in December will clarify which adverse events occurring in clinical trials must be reported to regulatory authorities
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Results form the 2,287-patient COURAGE trial presented the American College of Cardiology meeting should give physicians more to think about before moving forward with percutaneous coronary intervention in stable heart disease patients, researchers say.
FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a 1draft guidance released last week
Document will address premarket and postmarket recommendations for heavily scrutinized products.