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Common Technical Document
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521	Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format — Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical Data Management Drug safety Common Technical Document New Drug Application International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Center for Biologics Evaluation and Research Clinical research Research Medicine
522	Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Health Adverse Event Reporting System Center for Biologics Evaluation and Research Electronic Common Technical Document Center for Drug Evaluation and Research Abbreviated New Drug Application Title 21 CFR Part 11 Structured Product Labeling Food and Drug Administration Medicine Clinical research
523	Guidance for Industry M4: The CTD - Efficacy Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Drug safety Clinical Data Management Pharmaceutical industry Common Technical Document Clinical trial International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Food and Drug Administration Pharmacovigilance Clinical research Research Pharmaceutical sciences
524	Guidance for Industry ANDA Submissions — Content and Format of Abbreviated New Drug Applications DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Research Clinical research Pharmaceuticals policy Clinical Data Management Abbreviated New Drug Application New Drug Application Electronic Common Technical Document Generic drug Food and Drug Administration Pharmaceutical industry Medicine
525	Guidance for Industry M4Q: The CTD-Quality August 2001 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Medical informatics Common Technical Document Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Validation Package insert Clinical research Research Pharmaceutical sciences
526	Guidance for Industry M4: Organization of the CTD U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Pharmacology Common Technical Document Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document Clinical trial Food and Drug Administration Research Clinical research Pharmaceutical sciences
527	Specification for Transmitting Electronic Submissions using eCTD Backbone Specifications Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medical informatics Electronic Common Technical Document Competitions Digital media USB flash drive Universal Serial Bus Linear Tape-Open Digital Linear Tape Computer hardware Computing Clinical Data Management
528	Microsoft Word[removed]6_MK signed_8[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Pharmaceutical sciences Pharmaceutical industry Clinical research Clinical Data Management Investigational New Drug Title 21 CFR Part 11 Electronic Common Technical Document Electronic signature Medicine Food and Drug Administration Health
529	MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP[removed]OFFICE OF PHARMACEUTICAL SCIENCE Add to Reading List Source URL: www.fda.gov Language: English Business Clinical research Science Validity Hygiene Validation Sterilization Common Technical Document Specification Pharmaceutical industry Quality Technology
530	Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Pharmacology Medical informatics Electronic Common Technical Document Clinical investigator New Drug Application Center for Drug Evaluation and Research Food and Drug Administration Research Clinical research

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