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FDA trade union: trade union: annual returns, rules, statement to members, decisions and other related documents.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Enhanced collaboration with the US on med tech regulation, with accelerated innovation, strengthened patient safety, and reduced transatlantic barriers to market access.
As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
How test manufacturers or distributors can apply for approval of their tests to sell on the UK market.
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