Sec. Requirements for all expanded access uses. (b) Submission. (1) An expanded access submission is required for each type of expanded access.
The expanded access submission must include information adequate to satisfy FDA that the criteria in (a) and paragraph (b) of this section have been.
Sec. Requirements for all expanded access uses. . The expanded access submission must meet the requirements of (b). (1) If the drug is the.
21 cfr 312.305 b - agents
Individual patient expanded access permits physicians to use an investigational drug outside of a clinical investigation for an individual patient. This website has been translated to Spanish from English, and is updated often. Subpart I--Expanded Access to Investigational Drugs for Treatment Use. Links on this page:. It is possible that some links will connect you to content only. Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests. FDA Issues Simpler Draft Form for Individual Patient Expanded Access Applications.
FDA may ask a sponsor to consolidate expanded access under this section 21 cfr 312.305 b
the agency has received a significant Alberta Watson
of requests for individual patient expanded access to an investigational drug for the same use. A to Z Index. D, FDA Voice, A Big Step to Help the Patients Most in Need FDA Blog. Note: If you need help accessing information in different file formats, see. Depending on the type of expanded access, other sponsor responsibilities under subpart D may also apply. Information required for a submission may be supplied by referring to pertinent information contained in an existing IND if the sponsor of the existing IND grants a right of reference to the IND. In the case of any discrepancy in meaning, the English version is considered official.