The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits.

Currently, there are no FDA-approved therapies or vaccines for SARS-CoV-2, the virus that causes COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) is leading the funding of federal research and response to COVID-19, while...

The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients.

In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for p...

The US Food and Drug Administration (FDA) on Monday issued guidance allowing for limited expanded use of extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices during the coronavirus disease (COVID-19) pandemic.

The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduc assessments of Conform...