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How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
How we engage and involve patients and the public in our regulatory decision-making.
Patients requiring treatment outside of hospitals will be able to choose between multiple providers across the NHS and independent sector.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a case-control study to evaluate your digital health product.
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 for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
Actions that trial sponsors should consider to build resilience into clinical trial design
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How investigators and sponsors should manage clinical trials during COVID-19
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Forms and guidance for professionals working with restricted patients (mentally disordered offenders).
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
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