Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule

Fed Regist. 2010 Sep 29;75(188):59935-63.


The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

MeSH terms

  • Biological Availability*
  • Biological Products* / adverse effects
  • Biological Products* / pharmacokinetics
  • Biological Products* / pharmacology
  • Clinical Trials as Topic / legislation & jurisprudence
  • Drugs, Investigational* / adverse effects
  • Drugs, Investigational* / pharmacokinetics
  • Drugs, Investigational* / pharmacology
  • Humans
  • Investigational New Drug Application / legislation & jurisprudence*
  • Mandatory Reporting*
  • Safety / legislation & jurisprudence*
  • Therapeutic Equivalency*
  • United States
  • United States Food and Drug Administration


  • Biological Products
  • Drugs, Investigational