RegDesk Regulatory Roundup

FDA on MDDT (overview) FDA

FDA on MDDT (overview)

The new article provides an overview of a guidance document issued by the US regulatory authority and highlights the key points to be taken into consideration by interested parties with respect to the existing legal framework.  Table of Contents The Food and Drug...

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FDA on Q-Submission Program (SIR) FDA

FDA on Q-Submission Program (SIR)

The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...

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