Trusted Resource for Clinical Trials, Protocols & Progress
Post-marketing requirements are regulatory obligations mandated by FDA after a drug is approved for commercial use. These requirements aim to collect additional safety and effectiveness data, monitor real-world adverse events, and ensure risk mitigation. They are legally binding and noncompliance can lead to enforcement actions.
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REMS is a regulatory requirement under the FDA Amendments Act (FDAAA) of 2007. It is specifically mandated for drugs or biological products with serious safety concerns that cannot be mitigated through standard labeling alone. REMS ensures ongoing patient safety while allowing continued access to high-risk therapies.
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DCTs refer to trials where some or all trial-related activities occur at locations other than traditional clinical sites. These may include:
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FDA categorizes digital health to include a variety of tools and platforms used to support clinical care and wellness:
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