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制药提价与抑制仿制药方式 472条(本栏目收费,不能显示细节,电话13136136841)
drug product selection (DPS) laws, 20
20
drug safety and efficacy, 22, 28, 83
22 28 83
carve- out requests and, 103
103
companies claims of concerns over for product
hops and citizen petitions, 95
95
labeling information and, 109
109
Kefauver- Harris Amendments, 28
28
King Drug case, 61,65
61 65
King Pharmaceuticals, 105,108
105 108
labeling information carve- outs and, 109
109
Lamictal (anticonvulsant drug, Glaxo), 61,65
61 65
launching at- risk, 55
55
Lipitor (statin drug, Pfizer), 53,56
53 56
Medicare Modernization Act (2003), 33, 39
33 39
forfeiture provision for exclusivity period adjustments in Hatch- Waxman, 39,40
39 40
forfeiture provision loopholes and, 40
40
FTC v. Actavis, 43,45
43 45
FTC v. Actavis rule of reason test, 45,46
45 46
In re Cipro case (California Supreme Court) and, 46,47
46 47
increase in settlements since 2003 amendment, 40
40
non- cash provisions post- Actavis, 49,50
49 50
as procompetitive according to drug companies, 41
41
reverse payment schemes and, 35
35
settlement of Teva for provigil (narcolepsy drug), 47,48
47 48
six- month duopoly period and, 36,37
36 37
pay- for- delay settlements is that the incentives