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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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Japan MHLW Ordinance 28 Good Clinical Practice for Drugs, 12/12
Japan’s Ministerial Ordinance provides GCP standards to ensure the quality of clinical trials and the reliability of clinical trial data for drugs.
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FDA 21 CFR 211: Docket FDA-1997-N-0518, 3/12
This docket changed 21 CFR 211 to allow use of automated techniques to physically prevent incorrect labeling from being processed when cut labeling is used.
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EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples, 2/12
The European Medicines Agency (EMA) published this guidance. It was adopted by the Good Clinical Practices (GSP) Inspectors Working group on February 28, 2012.
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EC Proposed General Data Protection Regulation, 1/12
In January, 2012 the EC proposed this regulation. This regulation will impact several areas, including adverse event reporting and clinical trial data management.
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EC Medical Device Guidance: Qualification and Classification of Stand Alone Software, 1/12
In January 2012, the EC published this guidance to define the criteria for the qualification of stand alone software, when used in a healthcare setting as a medical device.
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FDA Guidance: Current Good Tissue Practice (GGTP) and Additional Requirements, 12/11
The US FDA published this Guidance for Industry to provide guidance on compliance with 21 CFR Part 1271, Current Good Tissue Practice.
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WHO Specifications for Pharmaceutical Preparations, 6/11
This WHO Expert Committee Report was published in 2011. Usage and controls for computerized systems are described throughout the documents.
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FDA 21 CFR 880: Docket FDA-2008-N-0106, 4/11
This FDA docket went into effect on April 18, 2011. With this change, the FDA exempted MDDSs from pre-market notification requirements.
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