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There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceuticalcompanies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.
When TS Eliot said humankind cannot stand very much reality, he obviously did not consider the virtual kind which is now heralded as the key for curing and preventing disease and picked as the potential lifeline for R&D in the pharmaceutical industry. “There is a real threat the pharmaceutical R&D industry could move offshore.”
This is to ensure patient safety, as outlined in The Medicines for Human Use (Clinical Trials) Regulations 2004. Current regulations for preclinical research In the UK, current regulation requires that all new medicines and vaccines be tested on animal models in preclinical studies, before being tested in humans in clinical trials.
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