Patient safety, news and press releases from EMA
- EMA website briefly unavailable on 3 December 2020, , 02/12/2020
- EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S , , 01/12/2020
- EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 , , 01/12/2020
- EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine, , 01/12/2020
- Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up, , 27/11/2020
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020, PRAC, 27/11/2020
- Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations, COMP, 24/11/2020
- Workshop on regulatory support for development of orphan medicines, COMP, 23/11/2020
- Update on remdesivir - EMA will evaluate new data from Solidarity trial, , 20/11/2020
- HMA/EMA statement on approval of vaccines, , 20/11/2020
MedWatch Safety Alert RSS Feed
- 2020 Safety Communications
- UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
- MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination
- 2020 Medical Device Recalls
- Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues
- WishGarden Herbs Issues Voluntary National Recall of 46 Units of Happy Ducts Compress Due to Bacterial Contamination
- Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements
- Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine
- Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error
- Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination