Category Guidance for industry

On mobile, the table below is best viewed by scrolling sideways. Title of guidance Type and level of guidance About the guidance Source Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Draft guidance This guidance (Guidance 3)…

Title of guidance Type and level of guidance About the guidance Source Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft guidance This guidance: • is intended to assist applicants and holders of an abbreviated new…

Title of guidance Type and level of guidance About the guidance Source Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Draft, level 1 guidance This guidance outlines recommendations intended to facilitate the use of DHTs in a clinical…

Last updated: 30 September 2021 Title of guidance Type and level of guidance About the guidance Source Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers This guidance provides information for firms about how FDA…

Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source ICH Q12: Implementation Considerations for FDA-Regulated Products Draft, Level 1 revised guidance This guidance should be read in conjunction with ICH…

Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Final FDA is issuing this…

Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source Providing Regulatory Submissionsin Alternate Electronic Format Final, Level 1 guidance This guidance provides recommendations on an alternate electronic format for submissions…

Title of guidance Type and level of guidance About the guidance What does the guidance not address ? Source Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Draft, Level 1 guidance This guidance provides…

Last updated on 28 May 2021 The US FDA has issued the following guidance documents for Industry in May 2021. Guidance Type and level of guidance About the guidance Scope of the guidance Source Procedures for Handling Post-Approval Studies Imposed…

The US FDA has FDA issued guidance on remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the pandemic. The final, Level 1 guidance is entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the…