Tag: MHRA
Paclitaxel controversy: Yes, device restrictions did cause harm
“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA) during...
New data and heated debates set to spark controversy in CX...
“These will be important, salutary lessons. Should a controversy arise again involving a proven efficacious therapy, we now know that stopping access to that...
UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for...
Following a review, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such...
UK MHRA awarded £10 million to fast-track patient access to medical...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of...
MHRA: Warning to be added to paclitaxel device IFUs in Europe
In a new field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will...
With national regulatory approaches diverging, FDA urges “global consensus” at VIVA
Many regulatory jurisdictions are establishing different approaches for medical devices, Misti Malone, assistant director in the Office of Cardiovascular Devices at the US Food...
Highlights from the CX 2019 session, Paclitaxel: the last word
Watch the video roundup from the CX2019 Highlight Session, Paclitaxel: The last word.
Filmed onsite at the Charing Cross Symposium (15–18 April 2019, London, UK).
MHRA issues medical device alert for paclitaxel use in the UK
Do not use paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs) in the routine treatment of patients with intermittent claudication until further notice, a...
MHRA limits routine clinical use of paclitaxel devices following expert advisory...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) acted to limit the future use of paclitaxel-eluting stents and paclitaxel-coated balloons in routine clinical...
