BIOE-225 Lecture Notes - Lecture 2: Medical Device Regulation Act, Morning Sickness, Thalidomide

• School: Lehigh University
• Department: Bio Engineering (BIOE)
• Course: BIOE-225
• Professor: Lori Herz

Document Summary

Requires new drugs to show safety before selling. In response to 300 deaths and injuries from tainted sulfathiozole. Requires fda to give manufacturers written reports of inspection observations. Requires proof that products work before they can be approved and sold. Ensures safety and effectiveness of devices; requires manufacturers to register with fda. Thalidomide: de(cid:448)eloped (cid:271)(cid:455) che(cid:373)ie gr (cid:374)ethal i(cid:374) (cid:1005)95(cid:1004)"s to treat (cid:373)or(cid:374)i(cid:374)g si(cid:272)k(cid:374)ess, caused physical disabilities in thousands of children, including flipper-like limbs, approval sought in us in 1960, but prevented, primarily by frances kelsey, m. d. , ph. d. (1914-2015) Not approved by fda; banned worldwide in 1962: today. Used to treat (cid:272)a(cid:374)(cid:272)ers (cid:894)(cid:373)ultiple (cid:373)(cid:455)elo(cid:373)a(cid:895), croh(cid:374)"s disease, a(cid:374)d m (cid:862)appro(cid:448)ed for (cid:373)arketi(cid:374)g o(cid:374)l(cid:455) through a spe(cid:272)ial restri(cid:272)ted distri(cid:271)utio(cid:374) progra(cid:373)(cid:863: has (cid:373)ade toda(cid:455)"s u drug la(cid:449)s (cid:373)ore stri(cid:374)ge(cid:374)t. Prevent poisonings: response to deaths from tainted tylenol capsules in. Promotes research, approval, and marketing of drugs for rare diseases. Allows approval of generics without repeating safety and efficacy studies.