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FDA Launching New Rules to Expand Access to Investigational Drugs
August 27, 2009
The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.
The rules, which go into effect in mid-October, clarify the procedures, standards and costs of providing investigational drugs as part of a clinical trial or when used outside the scope of a trial.
The FDA also has dedicated a portion of its web site to providing patients and health care providers with information about investigational drugs that have been approved by the FDA or are being given as part of clinical trials.
Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials
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