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Elizabeth Orr
Latest From Elizabeth Orr
Teleflex Subsidiary Faces Federal False Claims Investigation
Urology device developer NeoTract, which Teleflex purchased in 2017, is now under scrutiny for potential FCA violations.
US FDA Highlights OTC Market With Template To Boost COVID-19 Test Development
FDA template explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
FDA Boosts Development Of OTC COVID-19 Tests With New Template
A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
Final Guidance Addresses Regulation Of Multi-Function Products
The US FDA has finalized a guidance document on regulation of products with multiple functions that include non-device uses. While inspired by software regulation, the recommendations apply to all technology.
Guidance: FDA Acts To Improve Availability Of Viral Transport Media
The US FDA is relaxing some rules around viral transport media as part of its efforts to ensure supplies needed in the fight against COVID-19 reach US shelves.
FDA Action-Item List Shows Plans To Revamp De Novo, Combo Product, QSR Regs, And More
Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul.