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Federal rules and notices from the public comment record, analyzed continuously.
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Revising ANDA Labeling Following Revision of the RLD Labeling
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Submitting Continuous Glucose Monitoring Data in Clinical Trials Guidance for Industry
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Submitting Next-Generation Sequencing Data to the Division of Antivirals; Guidance for Industry
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FY 2018 Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
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Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Draft Guidance
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Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Guidance for Industry; Final Guidance
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Effectiveness of Anthelmintics: Specific Recommendations for Caprines; VICH GL14; Guidance for Industry; Final Guidance; #97
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Effectiveness of Anthelmintics: Specific Recommendations for Porcines; VICH GL16; Guidance for Industry; Final Guidance; #110
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Effectiveness of Anthelmintics: Specific Recommendations for Canines; VICH GL19; Guidance for Industry; Final Guidance; #111
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Effectiveness of Anthelmintics: General Recommendations; VICH GL7; Guidance for Industry; Final Guidance; #90
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Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus; VICH GL21; Guidance for Industry; Final Guidance; #114
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Effectiveness of Anthelmintics: Specific Recommendations for Ovines; VICH GL13; Guidance for Industry; Final Guidance; #96
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