BIO375H5 Lecture Notes - Lecture 6: Bioequivalence, Small Interfering Rna, Trastuzumab
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Depends on the type of products, like drugs, devices, ivd. Ivd have very similar gateway to medical device, so would (cid:374)ot (cid:271)e dis(cid:272)ussed i(cid:374) the (cid:272)lass, (cid:271)ut (cid:374)ote that the(cid:396)e"s o(cid:374)e (cid:373)ajo(cid:396) diffe(cid:396)e(cid:374)(cid:272)e which is clia (clinical improvement amendment). In 1937, many children died after receiving treatment from sore throat: added chemical to enhance the sweetness of the drug but it has negative side effect to children. Yes, the(cid:396)e"s a food a(cid:374)d d(cid:396)ug a(cid:272)t (cid:271)ut (cid:374)ot spe(cid:272)ifi(cid:272) e(cid:374)ough fo(cid:396) d(cid:396)ug safet(cid:455) and too general. A gatekeeper helps to check the safety of the drugs for everyone. A year later, in 1938, the food and drug act 1938 is introduced (modern version): Product needs to be safe before it goes to the market and required approval from us fda (gatekeeper). In canada, product license and monograph needs to be submitted before a drug is introduced into the market.
