FDA Enforcement Policy for PMA and HDE Supplements: Details
The present article describes in detail the policy followed by the authority concerning specific supplements.
The present article describes in detail the policy followed by the authority concerning specific supplements.
The article provides a general overview of the existing regulatory framework associated with adverse events.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the content of premarket submissions for software contained in medical...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to acceptance and filing reviews for premarket approval applications (PMAs). The present document...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has announced regulatory flexibilities for certain medical devices. The appropriate notice has been published on the official website of the Federal...