Regulatory affairs

LE WE PMID CA

Regulatory affairs

12390

Zulassung (MP Ph)

2011 1	Review of the processes for FDA oversight of drugs, medical devices, and combination products. [21204589] J Manag Care Pharm 17(1): 40-50 (2011)
2010 2	Regulatory actions on the off-label use of prescription drugs: ongoing controversy and contradiction in 2009 and 2010. [20866167] J Manag Care Pharm 16(8): 629-39 (2010)
2005 3	Methods for the comparative evaluation of pharmaceuticals. [21289930] GMS Health Technol Assess 1(-): Doc09 (2005)
2009 4	Methods for assessment of innovative medical technologies during early stages of development. [21289902] GMS Health Technol Assess 5(-): Doc15 (2009)
2010 5	Regulatory considerations for biosimilars. [21829775] Perspect Clin Res 1(1): 11-4 (2010)
2011 6	Role of centralized review processes for making reimbursement decisions on new health technologies in Europe. [22046102] Clinicoecon Outcomes Res 3(-): 117-86 (2011)
2011 7	Critics assail FDA medical device approval process: slow review time and safety are at issue. [21931470] P T 36(7): 395-409 (2011)
2007 8	Review of new regulations for the conduct of clinical trials of investigational medicinal products. [17635485] BJOG 114(8): 917-21 (2007)
2009 9	The RAC: double, double, toil, and trouble? [19247363] Mol Ther 17(3): 397-9 (2009)
2009 10	Recombinant DNA advisory committee updates recommendations on gene transfer for x-linked severe combined immunodeficiency. [19404322] Mol Ther 17(5): 751-2 (2009)
2011 11	Create a translational medicine knowledge repository--research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons? [21569250] J Transl Med 9(-): 56 (2011)
2010 12	Orphan drug: Development trends and strategies. [21180460] J Pharm Bioallied Sci 2(4): 290-9 (2010)
2010 13	Patent protection strategies. [21814422] J Pharm Bioallied Sci 2(1): 2-7 (2010)
2008 14	Points to consider on the non-clinical safety evaluation of anticancer drugs. [18544904] J Toxicol Sci 33(2): 123-6 (2008)

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