Attorney Patricia Kaufman says many stakeholders will be disappointed by the approach FDA has taken in its new intended use final rule.
FDA clears a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care ...
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.
FDA warns Chinas BBC Group about CGMP violations in its production of finished pharmaceuticals, along with unapproved new drug and misbranding issues....
FDA warns Sanit Technologies about CGMP violations in its production of finished drugs.
FDA cautions Stem Cell Therapy of Las Vegas that it is marketing unapproved cellular products and exosomes.
FDA clears a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthetic and 2D synthetic...
FDA releases its latest batch of Warning Letters that include BBC Group, Lepu Medical Technology and Sanit Technologies.