Recently Posted Guidance Documents

Recently Posted Guidance Documents

6/1/2020 - CVM GFI #240 Proprietary Names for New Animal Drugs 5/28/2020 - Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) 5/28/2020 - Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry 5/27/2020 - Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency: Guidance for Industry 5/27/2020 - Orange Book Questions and Answers Guidance for Industry: Draft Guidance for Industry 5/26/2020 - Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers 5/26/2020 - Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft Guidance for Industry 5/26/2020 - Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff 5/26/2020 - Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff