BfArM Guidance on Fast-Track Process for Digital Health Applications: Timeframes
The new article highlights the aspects related to the timeframes the applicants should follow.
The new article highlights the aspects related to the timeframes the applicants should follow.
The article provides a general overview of the existing regulatory framework associated with adverse events.
The new article highlights the aspects related to design considerations including control mechanisms to be implemented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The article highlights the key points related to the regulatory status of the products based on the existing legal framework. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the...