Literature DB >> 25952340

OARSI Clinical Trials Recommendations: An abbreviated regulatory guide to the clinical requirements for development of therapeutics in osteoarthritis.

L S Simon1.   

Abstract

In this brief abbreviated review of regulatory issues regarding the development of drugs and or devices for the treatment of osteoarthritis (OA), the steps that are expected by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are discussed.
Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  EMA; FDA; Osteoarthritis therapeutics; Regulatory

Mesh：

Year:  2015        PMID： 25952340     DOI： 10.1016/j.joca.2015.03.010

Source DB:  PubMed          Journal:  Osteoarthritis Cartilage        ISSN： 1063-4584            Impact factor:   6.576


  2 in total

1.  Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury.

Authors:  F E Watt; N Corp; S R Kingsbury; R Frobell; M Englund; D T Felson; M Levesque; S Majumdar; C Wilson; D J Beard; L S Lohmander; V B Kraus; F Roemer; P G Conaghan; D J Mason
Journal:  Osteoarthritis Cartilage       Date:  2018-08-18       Impact factor: 7.507

2.  The clinical efficacy of arthroscopic therapy with knee infrapatellar fat pad cell concentrates in treating knee cartilage lesion: a prospective, randomized, and controlled study.

Authors:  Yiqin Zhou; Haobo Li; Dong Xiang; Jun Zhu; Yi Chen; Qirong Qian; Jiahua Shao; Qiwei Fu; Yaguang Han
Journal:  J Orthop Surg Res       Date:  2021-01-28       Impact factor: 2.359
  2 in total

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