FDA has released a final guidance on Investigational New Drug (IND) Applications for Positron Emission Tomography (PET) Drugs that updates a draft released in February with only minor changes.
The guidance summarizes the IND process for unapproved PET drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug.
Along with minor edits, the final version clarifies that:
● the amount and depth of CMC information in an Expanded Access IND should be similar to the information necessary to support a phase 3 clinical trial. Expanded access is defined in the guide as a range of IND mechanisms intended to provide access to investigational drugs outside of traditional clinical investigations.
● radioactive drug substance manufacturing and control information may be provided in the application in the drug product section of the application if the drug substance is not isolated.
● Structure characterization data on nonradioactive drug substance as well as an analysis of the radioactive drug substance should be included in the application.
● in the “control of drug product” section, in addition to solvents, that membrane filter integrity, bacterial endotoxin testing, and sterility testing should be performed and submitted. Also added is a request for data from three batches, and a deletion of the requirement to provide additional data “when any changes are made in the specification.”
● in the “charging for an investigational PET drug” section, that: “FDA authorizes cost recovery only for the drug. Seeking cost recovery for monitoring or supportive aspects is beyond FDA’s purview.”
IPQ Monthly Update November 2012, pp. 35-37