共 8 条
[1]
Treatment use of an in-vestigational new drug.21 Code of Federal Regulations,312.34(b)(36). Investigational newdrug Application. www.ac-cessdata.fda.gov/ . 2005
[2]
Accelerated Assessment and Temporary Marketing Authori-sation in the European Union. Mats Ericson,,Christoper Webster,Francoise de Cremiers. RAJ pharma . 2004
[3]
Beyond Fast Trackfor Drug Approvals. Thomas G Roberts,Bruce A.Chabner. The new england journal of medi-cine . 2004
[4]
Fast Track Drug Development Programs-Designation,De-velopment and Application Review. http://www.fda.gov/cber/gdlns/ . 2006
[5]
Surrogate Markers-Their Role inRegulatory Decision Process. Aloka G.Chakravarty. www.fda.gov/cder/Offices/Biostatistics/ . 2003
[6]
Accelerated Approval of NewDrugs for Serious or Life-Treatening Illnesses.Scope 21 Code of Federal Regula-tions,314. FDA. www.accessdata.fda.gov/scripts/cdrh/ . 2005
[7]
Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses Purpose.21 Code of Federal Regula-tions,312.80. www.access-data.fda.gov/scripts/cdrh/ . 2005
[8]
FDA Finds New Ways to Speed Treatments toPatients. Ken Flieger. U.S.FDA Consumer special report . 2006