Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Etiometry, Modulim, Nico.Lab, Roche, University of California.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Biontech, Catalyst, Elusys, Kempharm, LG Chem, Mesoblast, Oyster Point, Pfizer, Protagonist, Regent, Telix, Vanda, Wanbang.
Cerus Corp. has received the green light from the U.S. FDA for its Intercept blood system for cryoprecipitation. The device, which garnered a breakthrough device designation in 2018, is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo) for treating and controlling bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO, National Academies report on AI in health care; Commerce begins assessment of U.S. drug, device manufacturing base.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bearpac Medical, Hologic.
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