![]() ![]() Comments submitted electronically, including attachments, to ![]() Submit electronic comments in the following way:įollow the instructions for submitting comments. You may submit comments on any guidance at any time as follows: Submit either electronic or written comments on the draft guidance by Januto ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. This draft guidance describes the process outlined in the GDUFA III commitment letter in greater detail and provides recommendations to DMF holders on how to provide the relevant information to FDA. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.” The purpose of this draft guidance is to provide information and recommendations on the Generic Drug User Fee Amendments (GDUFA) III program enhancements agreed upon by the Agency and industry in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter), related to the early assessment of certain Type II drug master files (DMFs) 6 months prior to the submission of certain abbreviated new drug applications (ANDAs) or prior approval supplements (PASs). Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
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