From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO reviews FEMA's pandemic supply chain management efforts; Testing lab owner sentenced to three years; Health Canada renews interim order for importation of devices; FDA: claims of registration certificates may be misleading; MDCG issues gap guidance pending Eudamed completion; FDA seeking nominations for advisory committee.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA updates recognized standards list; Advisory hearing scheduled for Transmedics’ OCS; GAO said ‘no’ to Spartan Medical appeal; CDC posts updates on SARS sequencing.
The separate “pass-through” payment Medicare provides for new, high-cost Part B drugs that are part of certain hospital procedures in the U.S. may be an incentive for hospitals to use those drugs rather than less expensive alternatives, according to a new Government Accountability Office (GAO) report.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA sees need for clarification of test coverage; MITA seeks transparency at USPSTF; NIH eyes license for cancer therapy; GAO says federal agencies falling short on recommendations; TGA updates guidance for risks in drugs and devices.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DoJ settles with alleged DME fraudster; GAO: Veteran’s community centers had issues before pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
The latest global regulatory news, changes and updates affecting biopharma, including: Biden orders review of scientific-integrity policies; Canada to build rare disease drug strategy; South African variant in U.S..
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.
