Combination products: Modernizing the regulatory paradigm

Nature Reviews Drug Discovery

Volumn 16, Issue 8, 2017, Pages 513-514

  Hunter, Nina L ^a   Sherman, Rachel E ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

DEVICE APPROVAL; DEVICE SAFETY; DRUG APPROVAL; DRUG ELUTING STENT; DRUG SAFETY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; HUMAN; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; RENAL REPLACEMENT THERAPY; REVIEW; TISSUE ENGINEERING; UNITED STATES; DRUG CONTROL; DRUG DESIGN; EQUIPMENT DESIGN; LEGISLATION AND JURISPRUDENCE; MEDICAL DEVICE REGULATION;

DEVICE APPROVAL; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG DESIGN; EQUIPMENT DESIGN; HUMANS; MEDICAL DEVICE LEGISLATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85026502234     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd.2017.66     Document Type: Review

References (2)

1. Drues, M. Combination products 101: A primer for medical device makers. Med Device Online https://www.meddeviceonline.com/doc/combination-products-a-primer-for-medical-device-makers-0001 25 Mar (2014).
2. Sivan, A. et al. Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Science 350, 1084-1089 (2015).