Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Beigene, Cerecor, Cyxone, Henlius, ITM, Ix, Takeda, Turning Point.
Airehealth Inc.'s management took a deep breath on hearing that the company's Vitalmed nebulizer received U.S. FDA 510(k) clearance after waiting nearly 11 months. The portable, electronic, vibrating mesh nebulizer will connect to the Orlando, Fla.-based company's diary companion app early next year as part of an integrated suite of products designed to help individuals with chronic respiratory issues track symptoms and better manage their care.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA issues guidance on enforcement policy regarding certain quality standards requirements under MQSA; MHRA looks to provide additional help post-Brexit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaite, Airehealth, Rheonix.
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices, beginning Dec. 1. New implantable devices will need to comply by Dec. 1, 2020, and existing implantable devices will have until Dec. 1, 2021, to comply.
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