In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by sponsors or manufacturers of investigational drugs that are eligible under the Right to Try Act, as well as the deadlines and content of those reports.
The Right to Try Act is one way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain investigational treatment options.
The purpose of this rule is to implement provisions of the FD&C Act added by the Right to Try Act, which requires sponsors and manufacturers who provide an “eligible investigational drug” under the Right to Try Act to submit to the FDA an annual summary of such use, and directs FDA to specify by regulation the deadline of submission.
The Mandatory reporting includes:
1. The name of the eligible investigational drug 2. The IND (Investigational New Drug) number 3. The number of doses supplied 4. The number of patients treated 5. The disease or condition that the drug is intended to treat 6. Information on serious adverse events
Click this LINK to know more about the Annual Summary Reporting Requirements Under the Right to Try Act Final Rule.
Once it is published it will be available on this page in an official form. Until then, you can download the unpublished PDF version.
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