Recentes

• ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
• Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
• IMDRF Document Implementation Report
• Acceptable Media for Electronic Product User Manuals
• FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
• Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings
• ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
• EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module