FDA approves a Teva Pharmaceuticals ANDA for the first generic version of Lundbecks Sabril (vigabatrin) 500 mg tablets for treating complex partial se...
FDA issues a revised draft guidance on common issues in drug development for rare diseases.
FDA clears an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use.
AdvaMed says updates to its code of ethics on interactions with healthcare professionals will take effect next 1/1.
FDA accelerates by two months the PDUFA review date for Nabriva Therapeutics Contepo antibiotic.
FDA orders about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections acr...
FDA commissioner Scott Gottlieb looks at ways the agency is coping with an upswing in cell and gene therapy INDs.
HHS secretary Alex Azar says progress is being made in reducing drug costs to consumers.