Literature DB >> 29491696

The 21st Century Cures Act: FDA Implementation One Year Later: Some Action, Some Results, Some Questions.

Stephen Barlas.   

Abstract

The Food and Drug Administration has made significant progress implementing some of the 60 provisions of the 21st Century Cures Act passed in 2016. The author discusses the successes and shortcomings of the agency's regulatory activities.

Year:  2018        PMID： 29491696      PMCID： PMC5821241     

Source DB:  PubMed          Journal:  P T        ISSN： 1052-1372


  2 in total

Review 1.  Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.

Authors:  Diane Stephenson; Robert Alexander; Varun Aggarwal; Reham Badawy; Lisa Bain; Roopal Bhatnagar; Bastiaan R Bloem; Babak Boroojerdi; Jackson Burton; Jesse M Cedarbaum; Josh Cosman; David T Dexter; Marissa Dockendorf; E Ray Dorsey; Ariel V Dowling; Luc J W Evers; Katherine Fisher; Mark Frasier; Luis Garcia-Gancedo; Jennifer C Goldsack; Derek Hill; Janice Hitchcock; Michele T Hu; Michael P Lawton; Susan J Lee; Michael Lindemann; Ken Marek; Nitin Mehrotra; Marjan J Meinders; Michael Minchik; Lauren Oliva; Klaus Romero; George Roussos; Robert Rubens; Sakshi Sadar; Joseph Scheeren; Eiichi Sengoku; Tanya Simuni; Glenn Stebbins; Kirsten I Taylor; Beatrice Yang; Neta Zach
Journal:  Digit Biomark       Date:  2020-11-26

2.  Design and development of referrals automation, a SMART on FHIR solution to improve patient access to specialty care.

Authors:  Anobel Y Odisho; Hansen Lui; Ramakrishna Yerramsetty; Felicisimo Bautista; Nathaniel Gleason; Edwin Martin; Jerry J Young; Michael Blum; Aaron B Neinstein
Journal:  JAMIA Open       Date:  2020-10-28
  2 in total

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