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drug launch

drug launch, Total:22 items.

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

US-CFR-file, drug launch

• CFR 21-822.15-2013 Food and Drugs. Part822:Postmarket surveillance. Section822.15:How long must I conduct postmarket surveillance of my device?
• CFR 21-822.3-2013 Food and Drugs. Part822:Postmarket surveillance. Section822.3:How do you define the terms used in this part?
• CFR 21-822.9-2013 Food and Drugs. Part822:Postmarket surveillance. Section822.9:What must I include in my submission?
• 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 21-814.3-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.3:Definitions.
• CFR 21-814.39-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.39:PMA supplements.
• 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 21-814.100-2014 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 21-73.530-2013 Food and Drugs. Part73:Listing of color additives exempt from certification. Section73.530:Spirulina extract.
• CFR 21-814.37-2014 Food and Drugs. Part814:Premarket approval of medical devices. Section814.37:PMA amendments and resubmitted PMAs.
• CFR 21-73.350-2013 Food and Drugs. Part73:Listing of color additives exempt from certification. Section73.350:Mica-based pearlescent pigments.

US-FCR, drug launch

• FCR 21 CFR PART 99-2015 DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
• FCR 21 CFR PART 99-2013 DISSEMINATION OF INFORMATION ON UNAPPROVED/ NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
• FCR 21 CFR PART 314-2013 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
• FCR 21 CFR PART 314-2014 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Group Standards of the People's Republic of China, drug launch

• T/SZCC 001-2023 Shenzhen biomedicine Industry "industrial upstairs"Design guidelines

RU-GOST R, drug launch

• 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

IX-EU/EC, drug launch

• 2008/31/EC-2008 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 98/8/EC concerning the placing of biocidal products on the market, as regards the implementing powers conferred on the Commission

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