Regulatory Surveillance Summary | December, 2019
By Laurel Hacche, SQA Associate SQA Regulatory Surveillance Summary for Q3-Q4, 2019 United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019 This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature. […]
Regulatory Surveillance Q1 2017 | Drugs, Devices, Biologics, Cosmetics, & Over-the-Counter Drugs
European Federation for Cosmetic Ingredients (EFfCI) No updates noted as of 09 March 2017 European Medicines Agency (EMA) Guideline on the Chemistry of Active Substances, 15 November 2016, EMA/454576/2016 The European Medicines Agency (EMA) has published a “Guideline on the Chemistry of Active Substances,” setting out information required by Directive 2001/83 with respect to the […]