Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Administrative / Procedural
Published
February 1, 2006
Last updated
May 13, 2021
Description
Draft guidance document on providing regulatory submissions in electronic format for orphan-drug and humanitarian use device designation requests.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)