Questions & Answers

How do I obtain orphan drug designation?

How do I prepare a Paediatric Investigation Plan (PIP)?

What kind of information should a package leaflet include to identify the medicine as an advanced therapy medicinal product?

Why are orphan drugs so expensive?

How do I progress from preclinical to clinical trials?

How do I get authorisation of administration of a drug under compassionate use?

Which is the difference between biomarker qualification and validation?

How do I obtain scientific advice for regulatory agencies?

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