FDA releases the FDA-483 with four observations from a 12/4-12/12/17 inspection at Switzerlands Akorn AG drug manufacturing facility.
FDA issues a document answering industrys questions on the agencys clinical data summary pilot program.
FDA releases an FDA-483 with six observations following an inspection at Infuscience, a sterile drug product producer in Eagan, MN.
Generic drug approval times for the second quarter of the current fiscal year dropped sharply, according to new FDA figures.
FDA issues a final order renaming and down-classifying needle destruction devices.
FDA commissioner Scott Gottlieb continues to use his bully pulpit to rail against the pharmaceutical industry and its increasing drug costs for Americ...
Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.
FDA issues a complete response letter for Sandoz BLA for a biosimilar version of Genentechs cancer drug Rituxan.