药品开发,固体口服剂型第二版 458条(本栏目收费,不能显示细节,电话13136136841)
Introduction.........96 96
Product Development.........97 97
Bioequivalency..........351 351
Prescription-to-OTC Switches......352 352
505(b)(2) NDAs.....352 352
Patent-Related Issues........355 355
Scope of Hatch–Waxman Patent Listing Provisions......355 355
30-Month Delay of ANDA and 505(b)(2) NDA Final Approval..........357 357
Hatch–Waxman Patent Infringement Litigation........358 358
Declaratory Judgment Actions.........358 358
Bolar-Type Considerations ......359 359
Authorized Generics........360 360
Miscellaneous.........362 362
Withdrawal of Approval of Innovator Drug......362 362
“Moving Target” and Disagreements with the FDA..........363 363
Application Approval Delays.......364 364
Therapeutic Equivalence........365 365
Risk Evaluation and Mitigation Strategies...365 365
Copyrighted Labeling........366 366
Antitrust Considerations.........366 366
Freedom of Information Act.......367 367
Clinical Trials Registry.....367 367
Compliance Issues.......368 368
“Fraud Policy”; cGMP Problems.....369 369