The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key…
Read MoreIn June, the Food and Drug Administration (FDA) issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria,…
Read MoreIn April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine…
Read MoreIn March, the Food and Drug Administration (FDA) issued a guidance, "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric…
Read MoreLast week, PRIM&R submitted comments in response to a request for information (RFI) on a draft report issued by the…
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