Biden’s Modernizing Regulatory Review – A New Paradigm?
The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). ...more
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in...more
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more