Category Guidance for industry

FDA issued guidance for industry – July 2021

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…

FDA issued guidance for Industry -June 2021

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…