Regulatory Challenges for Cartilage Repair Technologies

Cartilage

Volumn 4, Issue 1, 2013, Pages 4-11

  McGowan, Kevin B ^a   Stiegman, Glenn ^a  

^a Musculoskeletal Clinical Regulatory Advisers   (United States)

Author keywords

articular cartilage; clinical trials; FDA; regulatory affairs

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; ARTICULAR CARTILAGE; CARTILAGE; CARTILAGE REPAIR; CHONDROCYTE IMPLANTATION; CHONDROPLASTY; DRUG APPROVAL; DRUG MANUFACTURE; DRUG MARKETING; DRUG POTENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; MICROFRACTURE; NUCLEAR MAGNETIC RESONANCE IMAGING; TISSUE REPAIR; TOTAL KNEE REPLACEMENT; ARTHROPLASTY; CARTILAGE REPAIR DEVICE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; DIAGNOSTIC TEST APPROVAL; DISEASE SEVERITY; IMMUNE RESPONSE; MEDICAL DEVICE; MUSCULOSKELETAL DISEASE; OSTEOCHONDRAL DEFECT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; SYMPTOM ASSESSMENT;

EID: 84871172124     PISSN: 19476035     EISSN: 19476043     Source Type: Journal    
DOI: 10.1177/1947603512460756     Document Type: Article

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