Daily Rules, Proposed Rules, and Notices of the Federal Government
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FDA is announcing the availability of a guidance entitled “FDA Oversight of PET Drug Products—Questions and Answers.” In 1997, Congress passed the Food and Drug Administration Modernization Act (the Modernization Act) (Public Law 105-115). Section 121 of the Modernization Act directed FDA to establish appropriate approval procedures and current good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation timeline was instituted on December 10, 2009, when FDA published regulations that described the minimum CGMP standards that each PET drug manufacturer is to follow during the production of a PET drug (see part 212 (21 CFR part 212)).
Recognizing that many PET drug producers are unfamiliar with the drug approval process, FDA issued several guidance documents specific to PET drug producers
A draft guidance of the same title was announced in the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 FDA oversight of 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). The collections of information in 21 CFR part 314 were approved under OMB control numbers 0910-0001 and 0910-0338; the collections of information in 21 CFR part 312 were approved under OMB control number 0910-0014; the collections of information in part 212 were approved under OMB control number 0910-0667; the collections of information in 21 CFR parts 210 and 211 were approved under 0910-0139; and the collections of information in 21 CFR part 207 were approved under OMB control number 0910-0045. The guidance also refers to collections of information associated with submitting Form FDA 3397 (Prescription Drug User Fee Cover Sheet), approved under OMB control number 0910-0297.
Persons with access to the Internet may obtain the document at either