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New Regulations and Guidance Issued on Safety Reporting for Investigational Drugs and Products

Jun 23, 2011

In September 2010, the FDA finalized revisions to regulations on safety reporting requirements for investigational new drug and biologic products, acknowledging in its Federal Register announcement a need to focus reports on “relevant and useful” information. The regulations aim to enhance current reporting practices in three overarching ways:

1. Streamlining reports to focus on adverse events (AEs) evidenced to affect a drug’s safety profile;

2. Requiring expeditious reporting of drug effects suggesting significant patient risk identified in animal, clinical, epidemiological, and pooled analysis studies; serious events occurring in increased frequency than what is reported in a protocol or brochure; and serious events identified in all bioequivalence and bioavailability studies; and

3. Redefining terms and harmonizing reporting standards with recommendations set forth in the International Conference on Harmonisation guidance document E2A.

To assist sponsors and investigators in meeting the September 28, 2011, compliance deadline, the FDA issued accompanying draft guidance. The guidance outlines the nature, timing, and format for appropriate safety reporting. In addition to including examples of appropriate reporting scenarios, the guidance highlights areas of over-reporting by sponsors and offers clarifications on when and how those events should be addressed under the new rule.

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