Tag: Title 21 CFR Part 11

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Recent Related Articles to Title 21 CFR Part 11

Washington Healthcare Update - November 2020 #3

Added to Collection on: 2020-11-24 15:33:45

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Health sciences
Health
Food and Drug Administration
Emergency use authorization
Remdesivir
United States Department of Health and Human Services
Health Canada
Coronavirus disease
Pharmaceutical industry
Title 21 CFR Part 11
COVID-19 drug repurposing research
Moderna
Pfizer
United States
UnitedHealth

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Cognidox v10.1 delivers new features for FDA compliance

Added to Collection on: 2021-01-18 15:56:15

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Articles
Pharmaceutical industry
Health sciences
Computer law
Code of Federal Regulations
Health
Records management technology
Clinical data management
Title 21 CFR Part 11
GXP
Medical device
Electronic signature
Cognidox

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What Is Data Compliance?

Added to Collection on: 2021-02-09 00:00:00

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Health
Articles
Pharmaceutical industry
Pharmaceuticals policy
Computer law
Clinical data management
Food and Drug Administration
Laboratory information management system
Title 21 CFR Part 11
Electronic lab notebook
Data integrity
Regulatory compliance

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Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data ...

Added to Collection on: 2021-12-17 17:55:29

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Health sciences
Health
Clinical research
Pharmaceutical industry
Food and Drug Administration
Medical research
Clinical trial
Adverse event
ClinicalTrials.gov
Title 21 CFR Part 11
New Drug Application
Investigational New Drug

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FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges

Added to Collection on: 2021-12-29 20:30:10

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Health sciences
Food and Drug Administration
Health
Pharmaceutical industry
Clinical research
United States administrative law
Health informatics
Scott Gottlieb
Clinical trial
Title 21 CFR Part 11
Real world data
Michael R. Taylor
RWE GENERATION

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Q&A: The FDA's challenge in regulating evolving digital health tools | MobiHealthNews

Added to Collection on: 2022-10-15 04:41:56

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Food and Drug Administration
Health
Articles
Medical device
Office of In Vitro Diagnostics and Radiological Health
Validation
Criticism of the Food and Drug Administration
Title 21 CFR Part 11

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A Step Forward: FDA Issues Three Draft Guidance Documents As Part of Efforts to ...

Added to Collection on: 2023-09-19 18:04:34

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Food and Drug Administration
Medical device
Federal Food, Drug, and Cosmetic Act
FDA Center for Devices and Radiological Health
Investigational device exemption
Title 21 CFR Part 11

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Key Regulatory-Fueled Updates On Combination Products As We Enter 2024

Added to Collection on: 2023-12-15 16:59:07

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Food and Drug Administration
Pharmaceutical industry
Drug packaging
Regulatory affairs
Good manufacturing practice
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Medication
FDA Center for Devices and Radiological Health
Investigator's brochure
Title 21 CFR Part 11
Strategic Parenteral Solutions LLC

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