Pyramid Schemes and Pipeline Dreams: Adapting to a Tiered Regulatory System for New Drugs
This article was originally published in RPM Report
FDA's new drug safety authorities suggest that the focus of drug development and lifecycle management strategies need to change. It is no longer a question of what it takes to get approval from FDA, but rather what kind of approval you can get.
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Best of the Blog is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In November, Windhover's editorial staff posted 36 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. Highlights include : Fundrasing...Forget about it. Exits: Drought is an understatement. But there's new hope for biotech: In starkest terms, the regulatory system, the single biggest stumbling block to pharmaceutical success, is tilting biotech-wards.