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Approved Drugs

Approved Drugs, Total:17 items.

In the international standard classification, Approved Drugs involves: Medical sciences and health care facilities in general, Pharmaceutics, Test conditions and procedures in general.


US-FCR, Approved Drugs

US-CFR-file, Approved Drugs

  • 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 21-316.34-2013 Food and drugs. Part316:Orphan drugs. Section316.34:FDA recognition of exclusive approval.
  • CFR 21-822.7-2013 Food and Drugs. Part822:Postmarket surveillance. Section822.7:What should I do if I do not agree that postmarket surveillance is appropriate?
  • CFR 21-316.23-2013 Food and drugs. Part316:Orphan drugs. Section316.23:Timing of requests for orphandrug designation; designation of already approved drugs.

RU-GOST R, Approved Drugs

  • 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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