What We Really Need to Do about the FDA
The FDA bashers, led by Newt Gingrich, are doing the industry no good. Instead of making the FDA into a job-creating entrepreneur-supporting equivalent of the Commerce Department, we should be re-educating it to deal with the different rulemaking required for drug and device marketers who must sell to managed care organizations, not merely doctors.
You may also be interested in...
American Injectables plans to build up its US-based manufacturing after securing a commitment for $10m of ‘Series A’ financing from New Rhein Healthcare Investors, which it will use to scale up production and launch several generic parenteral products.
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.