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How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
How investigators and sponsors should manage clinical trials during COVID-19
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Guidance on transitional arrangements for the Clinical Trials Regulations.
Clinical trial applications that need expert advice from a specialist group or committee.
Guidance on the various types of modifications that can be made to a clinical trial approval.
Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatment of type 2 diabetes, weight management...
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