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Friday, January 28, 2022
Recently Posted Guidance Documents
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Recently Posted Guidance Documents
1/26/2022 -
Good ANDA Submission Practices Guidance for Industry
1/26/2022 -
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments: Guidance for Industry
1/26/2022 -
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff
1/26/2022 -
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders
1/26/2022 -
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
1/25/2022 -
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Draft Guidance for Industry
1/21/2022 -
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications Document
1/21/2022 -
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Draft Guidance for Industry, Investigators, and Other Stakeholders
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