Live-Licensing and In-life testing: R and D Processes and Regulation for New Drugs, 2008-2020
Visiongain predict that the current phase I to IV clinical testing process will eventually be selectively or wholly replaced by a system known as “in-life” testing or “live” licensing. Those proposals involve cumulative testing of the drug throughout its lifecycle. The industry would continually test drugs with smaller, more focused clinical trials. If a trial shows efficacy and safety, a live license would be given, allowing the company to market the drug in a limited manner. Already, the FDA and the EMEA have shown favourable interest in such developments - amongst other amendments to current practice.
In particular, R&D Processes and Regulation for New Drugs, 2008-2020, concentrates on the following essential aspects of the market:
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