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BioPharmaceutical Leadership Regulation

FDA Amendments Act: More Regulation = More Comfort and More Products

This article was originally published in RPM Report

  • Analysis

Executive Summary

Pharma companies are beginning to go to the financial community with an odd message: the companies are delighted to be getting more regulation from the Food & Drug Administration. The reason: the companies see a regulatory environment becoming ever more cautious and risk averse. The only solution is to make FDA more confidence about its decisions. The companies believe more regulatory authority for FDA on safety issues will make for a more confident and predictable regulatory agency.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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