Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Alr Technologies, Baxter, Tandem Diabetes Care.
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
The U.S. FDA’s device center is re-examining its approach to public safety communication, but Mark Leahey of the Medical Device Manufacturers Association said on a recent webinar that the FDA sometimes goes silent after an initial consultation with device makers about a safety signal.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis Biopharma, Hologic, Penumbra, Pixium, Think Surgical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J&J subsidiary agrees to settle off-label promotion allegations; FDA says ‘vulnerabilities persist’ in limited CDS programs.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading. Testifying in a Nov. 17 hearing before the Senate Banking Committee, SEC Chair Jay Clayton suggested a mandatory period of four to six months between implementing or materially changing a 10b5-1 plan and the first allowed stock sale. He added that the cooling-off period should at least cover a full quarter.
Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.
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