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EMA Scientific guidelines

Published by

Clinical DevelopmentClinical Trial DesignGuidelineRegulatory AdviceRegulatory Affairs

The European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Animal ModelBiomarkerCenter for Drug Evaluation and ResearchClinical DevelopmentDrug Development ToolEndpointQualification ProcessRegulatory AffairsResearch and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Clinical DevelopmentClinical Trial DesignRegulatory AdviceRegulatory AffairsSpecial Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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EU Compassionate Use Programs

Published by IRDiRC

Clinical DevelopmentCompassionate UseEarly Access SupportEMA Compassionate UseEuropean UnionOrphan DrugRegulatory AffairsResearch and Drug Development

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

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Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Clinical DevelopmentEarly Access SupportFDA Regulatory AdvicePatient AdvicePatient Affairs StaffPatient EngagementPatient SupportRegulatory AffairsResearch and Drug Development

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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