FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technology is becoming inc...
The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...
FDA warns Australias Cosmetics Manufacturers about CGMP violations in its production of drugs as a contract manufacturer.
Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial for treatment-resistan...
An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasize the need to seek i...
The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, bipartisan process.
Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping how pharmaceutical c...
As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to change medical device o...
