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.
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.
LONDON – An independent U.K. inquiry has found that failure to take seriously concerns raised by patients has resulted in life-threatening problems caused by medical devices and drugs being ignored for decades.
The industry is again preparing for a no-deal Brexit, as political shifts indicate that the U.K. crashing out of the EU on Oct. 31 is an increasingly likely outcome.
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