The latest global regulatory news, changes and updates affecting biopharma in Asia, including: FDA, Fresenius Kabi Oncology, Therapeutic Goods Administration, U.S. Department of Justice.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Shuren, Stenzel push back on serology tests; FDA touts accomplishments for 2020; IMDRF posts five-year plan.
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: MITA announces new health care supplier standard; Laggardly patient record response costs provider $75k; New med-tech resource platform now includes logistics; Spectrascience the subject of speculation, SEC action; HC nudging along with regulatory modernization plan.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS posts request for information for Lyme diagnostics; NICE: Stak device backed by one 35-enrollee study.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: EMA, Therapeutic Goods Administration, U.S. Department of Justice, U.S. Patent and Trademark Office.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts advisory for respiratory splitters; NICE: Propel device not ready for routine use; MITA sounds off on third parties with white paper; Ethicon, AIM settle on Esutures sales.
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.
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