Federal Register notice: FDA makes available a final guidance entitled Acceptance Review for De Novo Classification Requests.
Federal Register notice: FDA announces its adoption of the most current set of the Unified Code for Units of Measure codes.
Senator Richard Durbin (D-IL) urges FDA acting commissioner Ned Sharpless to take immediate action to curb the e-cigarette and vaping epidemic or resi...
FDA acting commissioner Ned Sharpless says the agency is just weeks away from announcing a new plan to modernize its technology infrastructure to help...
FDA denies a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on approval of any new ...
FDA issues two guidances related to medical device de novo classification requests one on performance goals and the other on user fee refund requests...
FDA issues a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products.
FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations.