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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over time.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Summary of the latest safety advice for medicines and medical device users
Guidance on labelling for medicinal products used in clinical trials.
How investigators and sponsors should manage clinical trials during COVID-19
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Guidance on using non-investigational medicinal products in a clinical trial.
How schools should setup a Microsoft Windows laptop or tablet before lending the device to a child, family or young person.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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