
Apr 15, 2022
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...
Read More

Apr 11, 2022
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...
Read More

Mar 30, 2022
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...
Read More

Mar 21, 2022
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...
Read More

Jul 12, 2021
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...
Read More