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Drug approved for marketing

Drug approved for marketing, Total:25 items.

In the international standard classification, Drug approved for marketing involves: Buildings, Farming and forestry, Pharmaceutics, Medical sciences and health care facilities in general, Test conditions and procedures in general.


US-FCR, Drug approved for marketing

US-CFR-file, Drug approved for marketing

  • CFR 21-814.3-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.3:Definitions.
  • CFR 21-814.84-2013 Food and Drugs. Part814:Premarket approval of medical devices. Section814.84:Reports.
  • CFR 21-814.20-2013 Food and Drugs. Part814:Premarket approval of medical devices. Section814.20:Application.
  • CFR 21-814.39-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.39:PMA supplements.
  • CFR 21-814.100-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.100:Purpose and scope.
  • CFR 21-814.116-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.116:Procedures for review of an HDE.
  • CFR 21-814.44-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.44:Procedures for review of a PMA.
  • CFR 21-814.104-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.104:Original applications.
  • CFR 21-814.37-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.37:PMA amendments and resubmitted PMAs.
  • CFR 21-822.15-2013 Food and Drugs. Part822:Postmarket surveillance. Section822.15:How long must I conduct postmarket surveillance of my device?
  • CFR 21-316.34-2013 Food and drugs. Part316:Orphan drugs. Section316.34:FDA recognition of exclusive approval.

Group Standards of the People's Republic of China, Drug approved for marketing

  • T/SZCC 001-2023 Shenzhen biomedicine Industry "industrial upstairs"Design guidelines
  • T/SHATCMI 0005-2023 Shang hai Quality Improvement Standard for Chinese Herbal sliles (Eleven traceable varieties in the first batch)
  • T/SHATCMI 0004-2023 Shang hai Quality Improvement Standard for Chinese Herbal sliles

Shanghai Provincial Standard of the People's Republic of China, Drug approved for marketing

RU-GOST R, Drug approved for marketing

  • GOST R 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals




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