Nov 15, 2023
FDA
The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
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Nov 29, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to De Novo Classification requests and the way they impact the FDA review clock and goals. The document...
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Nov 16, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document describing De Novo Classification Requests in the context of the effect on the FDA review clock and goals. The...
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Oct 21, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published several guidance documents dedicated to the De Novo Classification Process. One of the documents provides a brief overview of the...
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Oct 20, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and requests associated thereto. The document provides an overview...
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