United States, Food and Drug Administration | Office of Regulatory Affairs
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United States, Food and Drug Administration | Office of Regulatory Affairs
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The organization United States, Food and Drug Administration | Office of Regulatory Affairs represents an institution, an association, or corporate body that is associated with resources found in Biddle Law Library - University of Pennsylvania Law School.
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11 Items by the Organization United States, Food and Drug Administration | Office of Regulatory Affairs
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- Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation
- Guidance for industry : CGMP for phase 1 investigational drugs
- Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance
- Guidance for industry : Prescription Drug Marketing Act (PDMA) requirements, questions and answers
- Guidance for industry : computerized systems used in clinical trials
- Guidance for industry : electronic signatures, scope and application, Part 11, electronic records
- Guidance for industry : formal dispute resolution : scientific and technical issues related to pharmaceutical CGMP
- Guidance for industry : part 11, electronic records : electronic signatures--scope and application
- Guidance for industry : quality systems approach to pharmaceutical CGMP regulations
- Guidance for industry : standards for securing the drug supply chain : standardized numerical identification for prescription drug packages
- Guidance for industry : sterile drug products produced by aseptic processing, current good manufacturing practice
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.law.upenn.edu/resource/n5tP6IJQ5GY/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.law.upenn.edu/resource/n5tP6IJQ5GY/">United States, Food and Drug Administration | Office of Regulatory Affairs</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.law.upenn.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.law.upenn.edu/">Biddle Law Library - University of Pennsylvania Law School</a></span></span></span></span></div>
