Biologics License Applications (BLA)

Product,study,application,programs,therapies,process,benefit,control,review,biological products,clinical studies,regulatory authorities,regulations,blood,Biologics License Application,applicants,events,future events,interstate commerce,commercial products,preclinical studies,guidances,ongoing Phase,adverse event,marketing,concerns.

Regulatory approval,Breakthrough Therapy Designation,manufacturing process,potential impact,development program,priority review,compliance,responsibility for compliance,phase,conditional marketing authorization,opportunity,label,severe forms,Annual reports,protein products,product candidates,analogous product.

Allergenic product,dose escalation study,post-approval studies,Center,Breakthrough Therapy,cell therapies,licensing process,authority,impacts,reference,BioMarin,BioMarin Pharmaceutical Inc,BioMarin Pharmaceutical Inc.,severe hemophilia,hemophilia,form of hemophilia,Phase 3,blood component,marketing approval,health,Silver Spring,delandistrogene moxeparvovec,orphan drug designation,stages of development,surrogate endpoint,trade secrets.

Food and Drug Administration,drug substances,biological product file,risk to product quality,investigational product,applicable product,applications for combination products,applications for drug products,biological product INDs,biological product licensing provisions,biological product provisions,comparator product,Pediatric studies,study report,abbreviated application,application types,BLABiologics License Application,Center for Biologics Evaluation and Research,Center for Drug Evaluation and Research,Center for Biologics Evaluation and Research, Food and Drug Administration,Center for Drug Evaluation and Research, Food and Drug Administration,direct control,quality controls,consistent process controls,production process,Legal Authority,authority citation,guidance for industry entitled,draft guidance,FDA Guidance for Industry,Analysis of Environmental Impact,distributive impacts,robust quality assurance program,pivotal program,reference drug substance,incorporation by reference,applicable regulations,drug regulations,biologics license applicant,deemed-BLA applicants,Judicial review,therapeutic benefit,annualized cost-saving benefits,Compliance with requirements,donor blood,public health,Department of Health and Human Services,notice of opportunity,opportunity for hearing,container label,package label,absence of concerns,concern about fragmentation.