In the current Digital Age, we hear the term Machine Learning (ML) in almost every domain. But what exactly is ML? Simply, ML is a way of providing computers the ability to learn, improve and solve human problems. ML is...
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the expansion of remote MDSAP audits during the period of the public health emergency.1 Under this transmittal order, FDA clarifies the difference...
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers’ which was originally released in June, to give device sponsors additional time in...
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...
In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and BioNTech’s COVID-19 vaccine for use in individuals ages 16 and older. This allows for the first COVID-19 vaccine to begin being...
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...