In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrutiny of how cutting-edge biologics are marketed.
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical industry, according to a analysis by PharmaVoice.
In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrutiny of how cutting-edge biologics are marketed.
FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical industry, according to a analysis by PharmaVoice.
FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality checks.
Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered “bad” cholesterol compared with commonly used non-statin pills.
