Debunking the Instant Myth of FDA as Rubber Stamp

FDA's high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here's the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of [...]

Debunking the Instant Myth of FDA as Rubber Stamp 2015-08-21T15:24:01+00:00

Meeting the Challenges of Phase 2 Clinical Development

Some investigational products successfully make the transition from phase 2 to phase 3 while most fall by the wayside. Disregarding products that fail because they simply lack efficacy or safety, what makes the difference between phase 2 success for a relative few products and failure for most? In our view, the key to maximizing chances [...]

Meeting the Challenges of Phase 2 Clinical Development 2015-04-08T16:22:13+00:00
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