FDA issues two more Warning Letters to Web sites selling illegal opioids online.
FDA announces a 5/31 public hearing for it to receive input on the agencys regulatory strategy and pathways for products containing cannabis or cannab...
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram describe agency implementation of risk-based regulation of intentional genomic alte...
FDA warns Chinas Dong Yuan Technology Co. about CGMP violations in its production of finished pharmaceuticals.
A New York federal judge grants the government partial summary judgment in a whistleblower case alleging that Novartis participated in a company-wide ...
FDA issues a discussion paper seeking input on agency thoughts on regulating artificial intelligence and machine learning medical devices.
FDA issues Evoke Pharma a complete response letter on its 505(b)(2) NDA for Gimoti (metoclopramide) nasal spray for the relief of symptoms associated ...
Federal Register notice: FDA proposes to amend the biologics regulations by removing the specified test for the presence of mycoplasma for live virus ...