Archive


The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

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National Scientific Advice with HTA bodies

Published by IRDiRC

Regulatory AffairsNational Scientific AdviceHTA BodiesReimbursementHTA National

Regional and national HTA bodies in Europe, provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region. The assessment criteria used by HTA bodies differ between Member States, in accordance with regional and national legislation.

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The EMA describes extrapolation as extending information and conclusions available from studies in one or more subgroups of the patient population (source population(s)), or in related conditions or with related medicinal products, in order to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the amount of, or general need for, additional evidence generation (types of studies, design modifications, number of patients required) needed to reach conclusions.

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National programs for early access

Published by IRDiRC

Regulatory AffairsClinical DevelopmentCompassionate Use

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available

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