Blog Category: Biopharma

USA Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs The Food and Drug Administration (FDA or Agency) is announcing the availability...

USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...

In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority. The document is intended...

USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...

Rare diseases are a complex of over 5000 pathologies representing 10% of the entire human pathology. The European Commission decided to consider those pathologies whose incidence does not exceed 5...

AUSTRIA User Manual for Marketing Authorisation and Lifecycle Management of Medicines BASG published User Manual for Marketing Authorisation and Lifecycle Management of Medicines. How to login,...