ISSN: 2642-6315
Authors: Francois-Xavier Lacasse*
Over the last decade, the drug development landscape evolved sensitively with the increase of virtual companies. Numerous and promising new molecular entities and pharmaceutical technologies coming from universities and research centers were born. The generation of new start-up companies, most of them being virtual, has emerged. A lot of them are managed by brilliant scientists who forgot that science will never be better than regulatory requirements. Indeed, to become investigational new drug (IND) enabling candidates, whether we are talking about a medical device, new molecules or pharmaceutical technologies, these candidates will have to go through several steps that are mandatory prior to be tested in primary clinical studies on human. Furthermore, this observation has been noted in generic industry where some companies tried to become “FDA compliant” only by reading and applying FDA guidelines.
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