federal_register: 2022-10702

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2022-10702 Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017." This guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. This guidance is finalizing FDA's draft guidance for industry "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017," published in November 2019. 2022-05-18 2022 5 https://www.federalregister.gov/documents/2022/05/18/2022-10702/assessing-user-fees-under-the-generic-drug-user-fee-amendments-of-2017-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2022-05-18/pdf/2022-10702.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Assessing User Fees Under the Generic Drug User Fee Amendments of 2017." This guidance provides stakeholders information...  

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