Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...

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3/15/13% Why are Drugs Regulated Answer is obvious, but, as with most regulations, the rules are often written, or tightened after the “event”, in response to one or more health disasters: • 1907 - Introduction of arsphenamine (anti-syphilitic organic arsenical) • UK- Therapeutic Substances Act (1925) • 1937 - Elixir of Sulfanilamide - USA • Food and Drugs Act (1938) • 1957 - Introduction of Thalidomide (ex USA) • FDA introduced tightened approval requirements, regulation of advertising, and GMP inspections (1962) • UK Committee on Safety of Drugs (1963) • European Medicines Directive (1965) • UK Medicines Act (1968) Regulation of Medical Products Other public health problems that caused changes in regulatory control of medical products: • Viral/HIV contamination of blood & blood products • Tylenol contamination • CJD and prions in blood products • Counterfeit products – GMP • Heparin & melamine contamination – FDA overseas • Leaking breast implants • Malfunctioning medical devices • Fungal infections at compounding pharmacies 12%
3/15/13% Marcie Edmonds, 52, was stung in her abdomen last June at her Ahwatukee Foothills home in Phoenix. Eculizumab (Soliris) • Treatment for paroxysmal nocturnal hemoglobinuria • Most expensive drug in the world 13%
Page 1 and 2: 3/15/13% Novel Therapies: What Are
Page 3 and 4: 3/15/13% Medicinal “Nuts” • 6
Page 5 and 6: 3/15/13% Hydroxocobalamin Drug Deve
Page 7 and 8: 3/15/13% Transition probabilities 1
Page 9 and 10: 3/15/13% Prescription Drug User Fee
Page 11: 3/15/13% Standards in Drug Developm
Page 15 and 16: 3/15/13% 25.0 National Health Expen
Page 17 and 18: 3/15/13% Dr. Gleason Promoted Xyrem
Page 19 and 20: 3/15/13% FDA’s Deputy Commissione
Page 21 and 22: 3/15/13% lipidrescue.squarespace.co
Page 23 and 24: 3/15/13% Phase II Failures: 2008-20
Page 25 and 26: 3/15/13% Hydroxocobalamin: Cost Ana

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Objectives â¢ New drug approval process â¢ Pricing of new drugs â¢ Off ...