Federal Register Final Rule; technical amendment: FDA amends its regulations to reflect an organizational change for CDERs Office of Regulatory Policy...
FDA releases its latest batch of Warning Letters that includes Biotek Inc., Clover Custom Blending and Keshava Organics.
Two Sidley Austin attorneys caution that state tort suits against opioid manufacturers charging failure to provide adequate warnings raise significant...
FDA warns Clover Custom Blending about CGMP and misbranding violations in its production of finished pharmaceuticals.
FDA warns Indias Keshava Organics about CGMP deviations in the production of active pharmaceutical ingredients.
FDA clears a Canon Medical Systems USA 510(k) for a suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflamma...
Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee.
A recent inspection of a Cipla drug manufacturing plant in Goa, India cites significant GMP violations.