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The epidemiology, symptoms, diagnosis and management of human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2).
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
Submission dates and how the submissions using the EC decision reliance procedure work.
From 13 May 2024 we are introducing a change to the procedure for new Marketing Authorisation (MA) applications, where a joint assessment of labels is requested.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Check the tariff classification for surface-active preparation for washing the skin and the hair (gel 2-in-1).
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The mycology reference laboratory (MRL) provides a comprehensive laboratory service for the diagnosis and management of fungal infections.
Check the regulations on aircraft parts imported with a certificate of airworthiness.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
List of Field Safety Notices from 22 to 26 April 2024.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
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