Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision.
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November 20, 2014 Publishing & Submissions, Regulatory Intelligence, Regulatory Consulting -
Can more than one drug name appear in a CCDS? Who is the proper party to approve CCDS updates and revisions?This articles offers a framework and helps in understanding the role of the cross-functional teams and their undertakings that are involved in creation of a CCDS.
In Perspective
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August 5, 2014 Medical Devices, Regulatory Consulting, Publishing & Submissions, Health Authority UpdatesFDA has established a unique device identification number (UDI) so as to suitably distinguish medical equipment through their usage and distribution. Even though this system is now fully implemented in human-and-machine-readable form, the UDI compliance timelines are quickly getting shorter for companies to effectively plan their GUDID submissions to FDA.
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Drug Master File (DMF) is one of the important parts of the documents submitted to the regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).