A PDUFA 8 negotiating subgroup reviews industry’s counterproposal to FDA’s facility lifecycle proposal.
Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the branded version offered by Novo Nordisk.
A PDUFA 8 negotiating subgroup reviews industry’s counterproposal to FDA’s facility lifecycle proposal.
Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the branded version offered by Novo Nordisk.
FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system.
FDA publishes for public comment an International Council for Harmonization draft guideline on patient preference studies involving drug characteristics.
