PCL102H1 Lecture Notes - Lecture 16: Nasal Spray, Act Up, Thalidomide
16 Mar 2019
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Fda approvals occur between preclinical testing and clinic trials and after phase iii trials. Initial ind is to ask for permission to test in humans while nda/nds is to put on the market. Thalidomide was a drug that was approved for morning sickness but caused teratogenic effects in babies of mothers who took the drug. The thalidomide tragedy led to much stricter safety testing (e. g. us food, drug, and cosmetics act: much tighter safety regulation. Off-label use is very common and legal it up to the physician to decide what drug a patient gets. If they are prescribing medication off-label they need to rely on scientific and medical evidence because if they do not use good judgement, they are liable if there is an adverse reaction in patient. In addition, physicians should discuss potential risks and benefits, with patient and indicate use would be off-label (i. e. informed consent)
