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United States Food and Drug Administration Links
FDA.COM is not affiliated with the US Food & Drug Administration. This site is dedicated to Business helping Businesses - Contact FDA.GOV
HANDBOOKS
AND GUIDANCE
A must have for employees who work in the Medical Device industry. Includes requirements for Quality Systems and the Quality Management System
A great training and information tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing
A must have for employees who work in the Medical Device industry. Includes requirements for Quality Systems and the Quality Management System
Over 450 pages of Regulations and Guidance. Great for CMOs and Drug Industry. A great training tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing
The Produce Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Also available in
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Combination English / Spanish
Good Clinical Practices (GCP) Regulations for Drug Products - Last Updated 2024
A great training tool for the Dietary Supplement industry.
Over 300 pages of guidance and regulations to ensure your compliance is up to date!
For Companies that manufacture Drug, Medical Device and Combination Products
Over 900 pages of GMP guidances and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian, Japanese and Chinese GMPs!
For Companies that manufacture Drug, Medical Device and Combination Products
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21 CFR Part 11 - Electronic Systems
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21 CFR Part 210/211 GMPs for Finished Pharmaceuticals
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ICH Q7 GMPs for APIs
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EU Annex 1 Sterile Drug 2023
Over 88 pages of GMP Regulations for the Human Food Industry. The requirements for food facilities to follow to ensure the safety and quality of human food.
Good Clinical Practices (GCP) Regulations for Medical Devices - Last Updated 2024
The Laws and Guidance supporting the Controlled Substance Industry under US DEA Requirements.
