FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers
Source : Medtech Insight
Manufactures that have an emergency use authorized (EUA) product on the market due to the COVID-19 pandemic are still bound by the same regulations as other device-makers to notify regulators...
Generics Industry Fails To Match Last Year’s Growth In First Quarter
Source : 'Generics Bulletin'
After experiencing an exceptionally strong performance due to COVID-induced stockpiling and panic buying in the first quarter of last year, the generics industry largely saw revenues drop due to pandemic-related...
BGMA ‘Astonished’ By UK Government Snub
Source : 'Generics Bulletin'
Mark Samuels, CEO of the British Generic Manufacturers Association, has slammed the UK government after an extensive “Life Sciences Vision” strategy document published today contained no measures geared...
Pacifying A Pandemic With Numbers
Source : IN VIVO
A key reveal from this past year of pandemic response is how timely, accurate and accessible data can inform and guide health system decision-making. Good data, effectively applied, can transform...
Proposed Changes to Medicare Seek To Extend Add-On Payments, Expand Program For Homebound Patients
Source : Medtech Insight
In comments submitted to the US Centers for Medicare & Medicaid Services (CMS), industry and stakeholders expressed support for the agency’s planned extension of new technology add-on payments (NTAP) for...