Regulations and Guidelines
Showing 49–64 of 135 results
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Chinese Good Supply Practice for Pharmaceutical Products, 1/13
The 2013 Good Supply Practice for Pharmaceutical Products, includes the Chinese Ministry of Health’s requirements for use of computerized systems within the supply chain.
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EMA Reflection Paper on GCP for Trial Master Files, paper or electronic (draft), 12/12
The EMA drafted this reflection paper to set the requirements for Trial Master Files (TMF) to facilitate trial management, GCP compliance, and inspections.
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FDA Guidance: Clinical Performance Assessment, Considerations for Computer-Assisted Detection Devices Applied to Radiology Image, 7/12
This July 2012 US FDA guidance provides recommendations regarding clinical performance assessment of computer assisted detection (CADe) devices.
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FDA 21 CFR 1271: Human Cells, Tissues, and Cellular and Tissue-based Products, 4/12
This CFR part creates a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s).
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FDA 21 CFR 880: General Hospital and Personal Use Devices
21 CFR 880, General Hospital and Personal Use Devices, defines the FDA’s classification of commercially distributed hospital and personal use devices.
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FDA 21 CFR 820: Quality System Regulation
21 CFR 820, the Quality System Regulation, sets forth the current good manufacturing practice (cGMP) requirements for finished devices intended for human use.
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FDA 21 CFR 812: Investigational Device Exemptions
21 CFR 812 provides requirements for conducting of clinical investigations of medical devices.
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FDA 21 CFR 606: cGMP for Blood and Blood Components
21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
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FDA 21 CFR 600: Biological Products: General
21 CFR 600 applies to the manufacture, inspection, and adverse event reporting for any virus, therapeutic serum, toxin, antitoxin, or analogous products.
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FDA 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies
This CFR part prescribes good laboratory practices for conducting nonclinical laboratory studies that support applications for research or marketing permits for products.
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FDA 21 CFR 56: Institutional Review Boards
21 CFR 56 applies to the Investigational Review Boards monitoring clinical studies for drugs, medical devices,ﾠbiological products, supplements, formulas, additives.ﾠ
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FDA 21 CFR 50: Protection of Human Subjects
21 CFR 50 applies to clinical investigations, including drugs, medical devices,ﾠbiological products, dietary supplements, infant formulas, and food & color additives.ﾠ
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FDA 21 CFR 314: Application for FDA Approval to Market a New Drug
21 CFR 314 contains the requirements for FDA submission and review of applications and abbreviated applications to market new drugs.
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FDA 21 CFR 312: Investigational New Drug Application
21 CFR 312 contains requirements governing the use of investigational new drugs for FDA submission and review by of investigational new drug applications.
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FDA 21 CFR 211: cGMP for Finished Pharmaceuticals
FDA federal regulation for the manufacturing of finished pharmaceutical drug products.ﾠ
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FDA 21 CFR 210: cGMP in Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs provides definitions for terms used in 21 CFR Part 211, 600, 606, 1271, and others.
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