Drug Recall Updates: Regulatory Surveillance Summary – December 2019
This regulatory surveillance summary reviews key global regulatory developments from December 2019, including drug recall actions, FDA warnings, and compliance updates. By Laurel Hacche, SQA Associate 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 […]
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 […]