Day 1: US FDA Launches New 'Super Office,' Says It’s Already Proven Its Worth
Executive Summary
Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.
You may also be interested in...
More Changes At FDA With OST ‘Super Office’
The Office of Strategic Partnerships and Technology Innovation is being expanded to include five divisions, including the Digital Health Center of Excellence.
FDA Expands OPEQ ‘Super Office’; Splits In Vitro Diagnostics, Radiological Health Office In Two
The US agency’s Office of Product Evaluation and Quality also created new divisions in its Office of Regulatory Programs and Office of Clinical Evidence and Analysis.
New RWE Framework Aims To Get IVDs To Market Faster, Surveil COVID-19 Tests
Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.