Related by context. Frequent words. (Click for all words.) 65 Marketing Authorisation 64 Mutual Recognition Procedure 63 Marketing Authorization 59 orphan designation 58 Orphan Drug status 58 Orphan Drug designation 58 SCHWARZ PHARMA 57 Orphan Drug Status 57 Loramyc ® 56 Act PDUFA date 56 Marketing Authorization Application 56 Plenaxis R 55 Angiox 55 FIRAZYR 55 pediatric exclusivity 55 THELIN 55 Application MAA 55 Toctino R 54 Marketing Authorization Application MAA 54 Toctino ® 54 Complete Response 54 CHMP recommendation 54 ATryn ® 54 MHLW 54 USFDA approval 54 Paragraph IV 53 TRISENOX 53 DC Bead 53 Complete Response letter 53 Alitretinoin 53 Investigational Device Exemption 53 Commercialization Agreement 53 CE Marked 52 License Application 52 Notified Body 52 BioDelivery Sciences 52 PROVIGIL 52 Scientific Advice 52 DMFs 52 Clinical Trial Application 52 FDA approvable letter 52 ATryn R 52 Biotie Therapies Corp. 52 Orphan Drug Designation 52 BEMA Fentanyl 52 Rotarix R 52 ANDA approvals 52 SFDA approval 52 Orphan Medicinal Product 52 Patent Covering 51 Shelf Registration Statement 51 pitavastatin 51 Australian Therapeutic Goods 51 Argatroban 51 Apricus Bio 51 Biologics License Application 51 Pennsaid R 51 Fast Track Designation 51 REPLAGAL 51 Drug Applications ANDAs 51 Decapeptyl R 51 Orexo 50 Medicinal Products EMEA 50 Vitaros 50 CryoSeal FS System 50 orphan medicinal product 50 Transparency Directive 50 Icatibant 50 CE Marking 50 alvimopan 50 Product Characteristics 50 Virulizin R 50 ISTODAX 50 FFDCA 50 FDA Complete Response 50 FDA Orphan Drug 50 Hexvix 50 NOPR 50 Standard QIA 50 Competent Authority 50 eu domain name 50 Fibrillex TM 50 supplemental Biologics License Application 50 Chemicals Agency ECHA 49 Rhucin ® 49 MONOVISC 49 Mutual Recognition 49 Certificate STC 49 Final Approval 49 Actimmune R 49 END FOOTNOTE 49 Positive Opinion 49 silodosin 49 Andrx Corporation 49 WILEX 49 Regulatory Approval 49 VANTAS 49 Biotie 49 Fast Track designation 49 Stock Exchange CNSX 49 Recombinant Human