COVID-19

COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have received their first dose of the vaccine.1 This is excellent news, but you may be wondering what the next step...

Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the interim orders released during the pandemic.1 Since March 2020, Health Canada released five interim orders each of which...

Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandemic, there is an unprecedented number of EUA devices on the market, with many products being manufactured by...

Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered personal protective equipment (PPE) that helps in preventing exposure to particulates that spreads infectious diseases. A face shield...

Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...

Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions...