Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda Health, Whiterabbit.
In an open letter to Pfizer Inc. employees, the company’s CEO, Albert Bourla, provided some insight about why some countries don’t have COVID-19 vaccines and others have a surplus. It has nothing to do with intellectual property (IP), or even price, Bourla said.
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Bold, Cerecor, Foghorn, Organicell Regenerative Medicine, Pfizer, Rocket, Samus.
PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.
The FDA’s presenters at this year’s joint FDA/Xavier med-tech conference presented on a range of issues, such as the breakthrough devices premarket program and the agency’s postmarket surveillance efforts. However, the two FDA presenters both remarked that these functional areas are hampered by lack of resources, suggesting the agency has a unified message about resources that permeates negotiations for the next device user fee agreement.
HONG KONG – The Vietnamese Ministry of Health (MoH) has published a draft decree intended to refine the legal framework for regulating medical devices in the country. Released under the title Official Dispatch No. 2271/BYT-TB-CT, the draft document consolidates the amendments made to the current decree and introduces new sections addressing clinical trials, the Essential Principles for Safety and Efficiency of Medical Devices, and advertising.