PCL102H1 Lecture 17: Drug Approvals and the FDA

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Drug approvals and the fda: this takes place before phase 1 clinical trials and after phase 3 clinical trials. Thalidomide tragedy consequences: led to much stricter safety testing, 1938: u. s. food, drug and consmetics act, 1962: amendments, much tighter safety regulations. Introduced a new precedent in product regulation: proof of efficacy (shows that the drug works, required for all new drugs in order to receive market approval in the u. s, canada, uk, elsewhere: 1971. Durg approvals and fda/health canada decisions: clinical trial application (cta, before the clinical trial begins, request permission to distribute drug to investigators (scientists/doctors) named in the application. Information in the application: results from preclinical tests, production information how was the drug made, dosage form (pill/liquid/components/active-inactive) The review process: company submits new drug submission to tpd (health canada) I(cid:374)for(cid:373)atio(cid:374) a(cid:271)out the drug"s safet(cid:455: details about the production/manufacture, details about the package and label.

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