FDA Amendments Act: More Regulation = More Comfort and More Products
This article was originally published in RPM Report
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.