Related by context. Frequent words. (Click for all words.) 75 Complete Response Letter 72 approvable letter 71 Complete Response letter 64 Marketing Authorization Application 61 Warning Letter 60 Fast Track Designation 60 Biologics License Application 60 Priority Review 59 sBLA 59 Marketing Authorization Application MAA 58 Staff Determination Letter 58 Surfaxin 58 Fast Track designation 57 sNDA 57 Orphan Drug designation 57 PDUFA date 57 Orphan Drug Designation 56 Biologics License Application BLA 56 Marketing Authorization 55 European Medicines Evaluation 55 New Drug Application 55 FDA Approval 55 Drug Application 55 resubmission 54 Investigational 54 SILENOR TM 54 L MTP PE 54 NDA submission 54 APF# 53 Staff Deficiency Letter 53 Drug Candidate 53 pegloticase 53 pediatric exclusivity 52 alogliptin 52 ATryn R 52 Rhucin ® 52 PROMACTA 52 Paragraph IV certification 52 Satraplatin 52 methylnaltrexone 52 TORISEL 52 Horizant 52 CHMP 51 Completes Enrollment 51 BENLYSTA 51 Torisel 51 Phase IIa trial 51 OFIRMEV 51 REVLIMID R 51 vilazodone 51 Phase III Trial 51 BYDUREON 50 eltrombopag 50 Acetavance 50 Palatin Technologies Inc. 50 Regulatory Approval 50 diabetic neuropathic pain 50 EPIX Pharmaceuticals 50 ONSOLIS 50 PRX # 50 abatacept 50 Oracea 50 talactoferrin 50 Final Approval 50 ANDAs 50 iloperidone 50 orBec R 49 NUVIGIL 49 Promacta 49 CoFactor 49 Kuvan 49 PS# [001] 49 JANUVIA 49 Amigal 49 Investigational Device Exemption IDE 49 VIBATIV 49 Rhucin 49 PEG INTRON 49 ANDA 49 oritavancin 49 bifeprunox 49 StaphVAX 49 Ampligen R 49 Exalgo 49 Staff Determination 49 Cladribine Tablets 49 palifosfamide 49 confirmatory Phase 3 49 Cimzia ® 49 Combination Therapy 49 LIALDA 49 Telaprevir 49 ecallantide 49 investigational compound 49 Ampligen 48 lubiprostone 48 Taxotere ® 48 Dyloject 48 Abbreviated New 48 Naglazyme 48 Orphan Drug