Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?
Source : 'The Pink Sheet'
The coronavirus pandemic managed to change minds at the US Food and Drug Administration about innovative clinical trial designs, an attitude many hope remains once the public health emergency ends.
Safety...
Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use
Source : 'The Pink Sheet'
An internal memorandum the US Food and Drug Administration publicly shared on the day it was written shows how the agency made a potentially controversial decision on COVID-19...
How COVID Boosted Medtech In The Eyes Of The World
Source : IN VIVO
The famously fragmented medtech industry acted almost as one and found common ground with health care stakeholders from across the spectrum as never before during the COVID-19 crisis.
Reflecting on how...
Financial Penalties, COVID-19 Liability Top FDLI List Of Top Medtech Lawsuits
Source : Medtech Insight
Cigar manufacturers and payday lenders may not be what you think of when you think of the device industry, but lawsuits focused on those businesses could have ripple effects on...
To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
Source : Medtech Insight
To RRA, or not to RRA? That’s the question facing many medical device manufacturers that are being approached by the US Food and Drug Administration to participate in a virtual...