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Plan for the Implementation of Artificial Intelligence to Direct its Application in Medicine Regulation
access_time 2023-12-22T05:16:39.184Z face PharmaRIIM
Plan for the Implementation of Artificial Intelligence to Direct its Application in Medicine Regulation EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI ...
What is eCTD 4.0?
access_time 2023-12-04T09:43:10.119Z face PharmaRIIM
What is eCTD 4.0? The Evolution and Advantages of eCTD 4.0 in Global Regulatory Submissions Introduction: The Electronic Common Technical Document (eCTD) has become the standard format for submitting regulatory information to drug regulatory agencies globally. The release of eCTD 4.0 in 2022 marked...
FDA Purple Book
access_time 2023-10-31T15:21:56.732Z face PharmaRIIM
FDA Purple Book The US Food and Drug Administration (FDA) launches the first version of its searchable online database of biological product information, known as the Purple Book. “Purple Book” is different to “Orange Book,” the orange book is named for the FDA publication (Approved Drug Products w...