FDA
The new article describes in detail the approach to be applied with respect to meetings under the Q-Submission program and also clarifies the way unique numbers are assigned to incoming requests in order to ensure traceability. Table of Contents The Food and Drug...
FDA
The new article highlights aspects related to the content of the submission in the context of patient-matched guides. 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 describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The new article provides an overview of the guidance document describing the approach to be applied with respect to information the authority expects to be included in submissions for a specific type of product. Table of Contents The Food and Drug Administration (FDA...
FDA
The new article highlights the aspects related to how an applicant should submit requests for feedback and explains the approach to be applied with respect to combination products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
