Russia’s Sputnik V COVID-19 Vaccine Starts EU Rolling Review
Source : 'The Pink Sheet'
After some confusion over the status of its regulatory filing in the EU, Russia’s COVID-19 vaccine, Sputnik V, has finally begun a rolling review at the European Medicines Agency, based...
US FDA Needs Plan For Addressing Inspection Backlog Post-COVID, GAO Says
Source : 'HBW Insight'
The US Food and Drug Administration should ensure a backlog of overdue surveillance inspections growing due to COVID-19 travel restrictions doesn't compromise its capability to conduct “high-risk” inspections going forward,...
Coronavirus Notebook: Italy Makes First Use Of EU’s Vaccine Export Control System, More Regulators Issue Guidance On Variants
Source : 'The Pink Sheet'
Italy’s decision to prevent the export of 250,000 doses of the AstraZeneca/Oxford University COVID-19 vaccine to Australia may have hit the headlines yesterday, but reaction to the move by the...
US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
Source : 'The Pink Sheet'
The US Food & Drug Administration will downgrade some post-approval change classifications for manufacturers seeking to alter the materials used in container closure systems (CCS) for COVID-19 vaccines as well...
Direct Seller Representatives' COVID-19 Claims Sent To FTC By Industry Self-Regulation Group
Source : 'HBW Insight'
Fitness and health supplement direct seller RBC Life Sciences Inc. may face regulatory scrutiny in the US after ignoring an advertising self-regulation group’s questions about independent sales representatives’ COVID-19 claims...