The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy. Source: Devices & Diagnostics…
Roche’s late-stage COVID-19 trial of Actemra (tocilizumab) showed the rheumatoid arthritis drug reduced the number of coronavirus patients who progressed to mechanical ventilation, suggesting it might be of benefit as…
Leaders of the House Energy and Commerce committee on Friday lashed out at the Trump administration for allegedly blocking Commissioner Stephen Hahn from testifying about the agency’s COVID-19 response. Source:…
The direct molecular test received an initial FDA Emergency Use Authorization in March. Source: Devices & Diagnostics Letter
Athletes place the small round biosensor on the back of an upper arm. Source: Devices & Diagnostics Letter
Despite industry resistance and reluctance from state legislatures, the Trump administration is gearing up to issue a final rule allowing states to import prescription drugs from Canada as part of…
It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such…
Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the…
The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Source: The GMP Letter
The FDA has updated its policy on COVID-19 testing, clarifying that manufacturers of multi-analyte respiratory panels which include SARS-CoV-2 are now eligible for Emergency Use Authorization (EUA). Source: The GMP…