EMA – Revision 2 of the Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products
Year: 2024
Type: other
Abstract: The EMA published its Second revision of the Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products. This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in the treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical investigations to be conducted pre- and post-marketing authori...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12j9s
Author: Vroby
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6955221500
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