Category US FDA

EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…

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…