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USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA's Center for Devices and Radiological Health (CDRH)Â and the Center for Biologics Evaluation and Research (CBER) released a draft...

Sharan Murugan
Sep 6, 20242 min read
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EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms
Recently (19 January 2023) the European Medicines Agency released an updated guidance on "IRIS guide for applicants - How to create and...

Sharan Murugan
Jan 22, 20242 min read
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