Recently Posted Guidance Documents on Clinical Trials/GCP, Over-the-counter, User fees, ICH-Quality, and ICH-Efficacy

Recently Posted Guidance Documents

Over-the-counter

7/25/2017 Consumer Antiseptic Wash Final Rule Questions and Answers

User fees

7/25/2017 CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions

ICH-Efficacy

7/24/2017 PDEs for Triethylamine and for Methylisobutylketone

ICH-Quality

7/24/2017 Q3C Maintenance Procedures

7/24/2017 ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

7/24/2017 Q3C Tables and List Rev. 3

Clinical Trials/GCP

7/13/2017 IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects

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