Considerations for Complying with 21 CFR 211.110
January 2025 Docket Number: FDA-2024-D-5374 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine Download the Draft Guidance Document Read the Federal Register Notice This guidance, when...
Drug and Device Corner December 2024
The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user...
FDA issues final rule to broaden types of nonprescription drugs available to consumers
Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be...
Drug and Device November 2024
This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024. If you need help with your submissions, please...
21 CFR Part 11 and FDA Compliance
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology