FDA launches a new Web page that encourages firms to inquire about the agencys current policies on digital health products.
Federal Register notice: FDA seeks industry organizations to participate in selecting nonvoting industry representative to serve on CBERs Allergenic P...
FDA warns Chinas Bingbing Pharmaceutical Co. about CGMP violations in its production of finished drugs.
A Kaiser Health News special report says FDA sometimes approves expensive innovative branded drugs despite manufacturing issues found in pre-market in...
A McKinsey white paper describes a holistic approach to transforming drug development that could accelerate the process by 500 days and reduce the cos...
FDA awards AnaBios an Indefinite Delivery, Indefinite Quantity contract to access its adult human primary tissues and cardiomyocytes from organ donors...
The CDER Office of Prescription Drug Promotion wants to conduct research into how consumers and primary care doctors define and interpret 30 terms oft...
FDA clears a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immunodeficiency virus Ty...