The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS finalizes MCIT rule; HHS lists permanent waivers of notification; FDA schedules advisory meeting for latest Lutonix model; HHS announces telehealth grants; Telemarketer caught in sting over telehealth fraud; Churn at FDA chief counsel’s office.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO shoots down Draeger appeal of VA bid; Three EU nations join stockpile program.
The latest global regulatory news, changes and updates affecting biopharma, including: Drug safety in pregnancy mission of new U.K. consortium; FDA identifies regulatory science needs; HHS finalizes regulatory review rule; Doctor pleads guilty to trial fraud.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA formally posts testing advisory after town hall discussion; HHS finalizes regulatory review rule; Lab in California hit for three months of false claims; BVMed calls for German med tech strategy.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS unveils $22B testing fund; Trade associations sound off on Capitol Hill pandemonium; FDA reopens recall docket; Health care bills become U.S. law.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO says wound care spending dropped between 2016 and 2018; FDA updates COVID testing data; May 2019 Q-sub guidance appears in final form.
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