FDA warns Chinas Guangzhou Tinci about CGMP violations in its production of finished pharmaceuticals.
A CDRH Webinar explains provisions of an immediately-in-effect guidance on coronavirus tests developed in certain certified laboratories.
AnaBios and FDA sign a research collaboration agreement to study adult human primary cardiomyocytes as a reference for cellular properties and drug-in...
In an 81-page letter, PhRMA explains its opposition to an FDA proposed rule to establish a process to permit some drug importation.
HeartWare recalls (Class 1) its Ventricular Assist Device system battery charger due to the potential for the charger to be mistakenly inserted into t...
Some 41 members of Congress ask FDA commissioner Stephen Hahn to implement a new guidance on developing treatments for ALS.
Former FDA commissioner Scott Gottlieb says the federal government was late in bringing academic and private laboratories into the process of coronavi...
FDA releases its latest batch of Warning Letters that includes Guangzhou Tinci Materials Technology and James R. Corbett.