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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

• 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
• 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 814-2015 PREMARKET APPROVAL OF MEDICAL DEVICES
• FCR 21 CFR PART 814-2014 PREMARKET APPROVAL OF MEDICAL DEVICES
• FCR 21 CFR PART 814-2013 PREMARKET APPROVAL OF MEDICAL DEVICES

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

• DB31/ 575-1-1992 Inspection Standards for Major Crop Seeds in Shanghai
• DB31/ 575-2-1992 Grading Standards for Major Crop Seeds in Shanghai
• DB31/ 575-3-1992 Shanghai Standards for Main Crop Seed Storage

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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