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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warns about differing complication rates for acellular dermal matrix; CDC and NIH initiate COVID-19 self-testing pilot program; GHIT invests $21M; MHRA updates guidance.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel.
In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
LONDON – The life sciences industry exhaled sharply and prepared to labor over the fine print in 1,246 pages of text after the EU and U.K. reported they had agreed a post-Brexit trade deal on Christmas Eve. The U.K. has said it will take a light touch, at least initially, with implementation of new border controls taking place in three stages up to July 30, 2021. The EU has not said what its approach will be.
LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.
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