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.
You may also be interested in...
Kaiser Pushes Back on REMS: Acorda Listens; Will FDA?
Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.
Novartis Pediatric Post-Market Plans For Xolair Fall Short Of FDA Request
A post-market program designed by Novartis to control Xolair (omalizumab) in the 6-11 pediatric population was not adequate to convince FDA or its Pulmonary-Allergy Drugs Advisory Committee to extend the indication for use in moderate to severe allergy/asthma patients below 12 years of age
Genentech Aborts Raptiva Amidst Reports Of Fatal Brain Infection
Risk management program couldn't save psoriasis drug. Decision is final, firm says.