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In the News: October Regulatory and Development Updates

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

Development 242
Development Bioequivalency Generic Drugs Production 242
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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis.

Clinical Trials 52
Clinical Trials Clinical Trials Production Medicine 52
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