Related by context. Frequent words. (Click for all words.) 62 FFDCA 61 FDA Orphan Drug 59 Orphan Drug status 59 orphan designation 59 orphan medicinal product 58 TYGACIL 58 FDA Accepts 58 FDAAA 58 Marketing Authorisation 58 Act PDUFA date 57 CHMP recommendation 57 Orphan Medicinal Product 57 refractory chronic lymphocytic 57 Clofarabine 57 IND Investigational New 57 Initiate Phase 56 Investigational Device Exemption 56 Fast Track Designation 56 END FOOTNOTE 56 Vandetanib 56 CFR § #.# [007] 56 CFR #.# [007] 56 Australian Therapeutic Goods 56 FIRAZYR 56 Pivotal Phase III 56 phase Ib 56 Recommended Practices 56 Clevudine 56 Pirfenidone 55 Vitro Diagnostic 55 Medicinal Products EMEA 55 Argatroban 55 relapsing multiple sclerosis 55 Belimumab 55 Research CDER 55 Ixempra 55 liposomal formulation 55 Orphan Drug Status 55 NOXAFIL 54 Coadministration 54 Marketing Authorization 54 PRIALT 54 Regadenoson 54 CIMZIA TM 54 Golimumab 54 APPROVAL OF 54 Cethromycin 54 BEXXAR 54 CFR § #.# [006] 54 Orphan Drug Designation 54 BLA submission 54 rilonacept 54 Drug Application 54 Ambrisentan 54 Icatibant 54 Panzem R 54 NOPR 54 ATryn ® 54 Pennsaid R 54 supplemental Biologics License Application 54 Drug Submission 54 Act PDUFA 54 MERLIN TIMI 54 CGMP 54 Alitretinoin 54 Recombinant Human 54 Drug Candidate 54 Pivotal Phase 54 Ceftobiprole 54 Confirmatory 54 Project BioShield Act 54 Plenaxis R 54 Telavancin 53 Amrubicin 53 #/#/EC [002] 53 alvimopan 53 Swissmedic 53 Marketing Authorization Application 53 LIALDA 53 ezogabine 53 DDP# 53 Anthim 53 etravirine 53 Mitigation Strategy 53 MHLW 53 Alemtuzumab 53 SUPPLEMENTARY INFORMATION 53 Mitigation Strategy REMS 53 romiplostim 53 OPANA ER 53 Prescribing Information 53 Product Characteristics 53 Biologics License Application BLA 53 application sNDA 53 pediatric exclusivity 53 Orphan Drug designation 53 ixabepilone 53 TRISENOX 53 Arch Neurol 53 Pulmonary Arterial Hypertension 53 Income Tax Regs