Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit electronic comments on the guidance to
FDA is announcing the availability of a guidance entitled “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.” The guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug.
A draft guidance of the same title was announced in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the submission of INDs for PET drugs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). INDs and requests to charge for a drug under an IND are submitted to FDA under part 312 (21 CFR part 312). New drug applications and abbreviated new drug applications are submitted to FDA under §§ 314.50 and 314.94 (21 CFR 314.50 and 314.94). The collections of information in part 312 and in §§ 314.50 and 314.94 have been approved under OMB control numbers 0910-0014 and 0910-0001.
Persons with access to the Internet may obtain the document at either