FDA
The new article highlights the aspects related to the scope of information to be documented in the context of pathology peer review. Table of Contents The Food and Drug Administration (FDA), the US regulatory agency in the sphere of healthcare products, has published...
FDA
The new article highlights the aspects related to the cases when the authority takes negative decisions with respect to the application submitted, the applicant decides to withdraw the application itself, as well as the key performance goals. Table of Contents The...
FDA
The article addresses the key points related to the pathology peer review for a specific type of nonclinical investigation. 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 highlights the aspects related to the actions taken by the applicant and their impact on the review clock and timelines. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The article provides an overview of the performance goals related to the applications under the premarket approval framework. 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 article provides a general overview of the approach to be applied with respect to the review clock in the context of applications for marketing approval. The document also describes the main regulatory actions to be taken by the authority based on the application...
