Regulatory Updates – March 2020
FDA: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Read More… FDA: Product-Specific guidance for generic
Regulatory Update – Feb 2020
FDA: Promotional Labelling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers (Draft guidance) Read More…
Critical Role Of Labelling Management In Regulatory Affairs
Andy Thornley PhD, Senior Regulatory Consultant Overview Labelling for human healthcare products (i.e. medical devices, medicines, cosmetics, vitamins, and dietary