Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry

Information

Type

Guidance

Regulated products

Animal & Veterinary, Biologics, Cosmetics, Dietary Supplements, Drugs, Food & Beverages, Medical Devices, Tobacco

Topics

Compliance, Electronic Submissions, Import, Inspection, Records

Published

February 2, 2024

Last updated

September 4, 2024

Description

Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and pharmaceutical quality.

Organization

Country / Region

United States

License

Other (Public Domain)

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