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What is a 21 CFR Part 11 Compliant Document Management System?

Discover how a 21 CFR Part 11 compliant Document Management System ensures FDA compliance, secures electronic records, and streamlines document control in regulated industries.
https://amplelogic.com/21-cfr-part-11-compliant-document-management-system - Details - Similar

U.S. Food and Drug Administration

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation s f
https://www.fda.gov/ - Details - Similar

Contact FDA | FDA

Contact information for the U.S. Food and Drug Administration.
https://www.fda.gov/about-fda/contact-fda - Details - Similar

About FDA | FDA

General information about FDA – its mission, history, organization, partnerships, etc.
https://www.fda.gov/about-fda - Details - Similar

MedWatch: The FDA Safety Information and Adverse Event Reporting Progr

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program - Details - Similar

Recalls, Market Withdrawals, Safety Alerts | FDA

FDA and industry press releases regarding product recalls
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts - Details - Similar

FDA Modernization Efforts for Establishing a Unified Human Foods Progr

Implementation occurred on Oct. 1, 2024
https://www.fda.gov/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and - Details - Similar

Search for FDA Guidance Documents | FDA

Search for official FDA guidance documents and other regulatory guidance.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents - Details - Similar

FDA en español | FDA

La FDA es responsable de proteger la salud pública asegurando la seguridad, eficacia y protección de los medicamentos, los productos biológicos y los dispositivos médicos humanos y veterinarios; y asegurando la seguridad
https://www.fda.gov/fda-en-espanol - Details - Similar

Electronic Common Technical Document (eCTD) | FDA

Electronic Common Technical Document (eCTD) mandatory use for some submissions starts May 2017. eCTD is the standard format for electronic reg submissions.
https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd - Details - Similar

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