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Linde Healthcare
Postboks 13 Grefsen
NO-0409 Oslo
Norway
Phone +47 815 59 095
Fax +47 23 17 73 10
healthcare@no.aga.com

Standarder og regelverk for medisinske gasser i USA

  • Food and Drug Administration (FDA) Current Good Manufacturing Practise cGMP
  • United States Pharmacopea USP
Legemidler
  • 21 Code of federal regulations 21 CFR 200
  • Investigational New Drug IND
  • New Drug Application NDA
Medical drug
  • 21 Code of federal regulations 21 CFR 800
  • Quality system regulations
  • Investigational Device Exemption IDE
  • Premarket Approval PMA
  • Premarket Notification 510(K)