FDA
The new article highlights certain specific aspects to be considered, including design controls and following steps in clinical evaluation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article is dedicated to iterations during early feasibility studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article provides additional details regarding specific aspects related to the report of prior investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
FDA
The new article provides additional details regarding the regulatory framework for early feasibility studies and covers the associated aspects, including, inter alia, targeting approval. Table of Contents The Food and Drug Administration (FDA or...
FDA
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 the early collaboration meetings in the context of the FDA Modernization Act (FDAMA). The latest version...
