Related by context. Frequent words. (Click for all words.) 55 QbD 54 pharmacogenetic 52 CDER 52 PGx 51 pharmacogenomic 50 pharmacogenomics 50 CGMP 50 pharmacoeconomic 50 immunoassays 50 diagnostic assays 49 Vilazodone 49 REMS 49 Proposed Regulations 48 companion diagnostics 48 MassARRAY 48 theranostics 48 FDA 48 FIFRA 48 BLA submission 48 molecular diagnostic 48 Proposed Rule 48 pharmacogenetics 48 Exelbine 48 ADME 48 OVA1 48 genotyping 47 EMTALA 47 biomarkers 47 postmarket 47 Complete Response 47 molecular profiling 47 AspenBio 47 ATL# [001] 47 generalizability 47 biomarker 46 SNP genotyping 46 biopharming 46 protein biomarker 46 LC MS MS 46 FENTORA 46 Biosimilars 46 CLIA certified 46 metabolomics 46 NeutroSpec 46 renal toxicity 46 therapeutic monoclonal antibodies 46 Research CDER 46 Pirfenidone 46 Mitigation Strategy REMS 45 NPDES 45 Thyrogen 45 myeloproliferative disorders 45 genotoxicity 45 Ampligen 45 clinical 45 ONSOLIS 45 MammaPrint 45 GeneChip 45 alvimopan 45 biomarker discovery 45 ADME Tox 45 genomic 45 NOXAFIL 45 MTWA 45 Horizant 45 biologic treatments 45 CFR ยง #.# [007] 45 serologic 45 GEIS 45 vitro diagnostic 45 RRGs 45 PDUFA 45 phenotyping 45 diagnostic tests 45 Plenaxis R 45 HIQA 45 GMPs 44 SmartChip System 44 nucleic acid amplification 44 Vandetanib 44 HuCNS SC cells 44 DNA Sequencing 44 SinuNase 44 Complete Response letter 44 inventorship 44 Synthon 44 Onalta 44 Mylotarg 44 EU Directives 44 diagnostic 44 protein biomarkers 44 placebo controlled studies 44 Biomarker 44 patentable subject 44 MAbs 44 Lumizyme 44 approvability 44 Affymetrix GeneChip R 44 antiviral therapies 44 Cethromycin 44 CDRH