Former FDAer Steve Lynn asks what the drug industry and regulators can do working together to break the cycle of more than 20 years of the same CGMP i...
Federal Register notice: FDA selects interested industry organizations to participate in selecting nonvoting industry representatives to serve on cert...
Federal Register notice: FDA grants a special termination of the debarment of David Winne due to his cooperation with federal officials.
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assessments on their sickl...
An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will continue.
A Florida federal judge sentences Marina Sievert to two years in federal prison for mail fraud and introducing into interstate commerce a foreign unap...
Tonix Pharmaceuticals discontinues the development program for major depressive disorder candidate TNX-601 ER based on disappointing efficacy results ...
Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications between companies and ...
