Drug and Device Constituent Update 2025 April
We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes. The following 3 points have come to our attention in the last few days. For any questions regarding the status of a product in the NDC Directory,...
Cosmetic Registration and Listing Requirement Reminder
Now that we have entered the first year post cosmetic registration and listing requirements, it’s a good time to review your records and make sure you are prepared for your update / renewal process. For facility registrations, an update should be submitted within 60...
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
For Immediate Release: December 26, 2024 Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if...
FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products
Read on FDA Site Cosmetics Constituent Update December 11, 2024 The U.S. Food and Drug Administration (FDA) issued updated guidance entitled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. In summary, the guidance finalizes...
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