Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try

The Food and Drug Administration (FDA) has a system, known as expanded access, to provide investigational drugs outside of clinical trials. Critics of this program have said that it is cumbersome and discourages many patients and physicians from applying, although the FDA revised their procedures in 2015 to make the process more user-friendly.

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FAMAR

Established in 1949 in Greece, FAMAR is one of Europe’s leading providers of Contract Manufacturing and Development Services to the Pharmaceutical and Health & Beauty industry.

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Research and Development in the Pharmaceutical Industry

whitePaper | April 1, 2021

Every year, the U.S. pharmaceutical industry develops a variety of new drugs that provide valuable medical benefits. Many of those drugs are expensive and contribute to rising health care costs for the private sector and the federal government. Policymakers have considered policies that would lower drug prices and reduce federal drug expenditures. Such policies would probably reduce the industry’s incentive to develop new drugs.

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Transforming Patient Journey in Clinical Trials

whitePaper | April 7, 2022

Year after year, the Life Sciences industry expands at a breakneck pace, with pharmaceutical development leading the way.

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Access to medicinal products

whitePaper | January 3, 2022

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs

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Pharma R&D Annual Review 2022 Navigating the Landscape

whitePaper | May 7, 2022

Citeline, Welcome to Pharmaprojects' 2022 reviews of trends in pharmaceutical R&D. Take a look at the evolution of pharma R&D and in this article, examine the state of play at the start of 2022.

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Non-Clinical Testing Considerations: Drugs vs Devices

whitePaper | November 8, 2022

While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most important difference is that medical devices do not achieve their principal action by pharmacological means.

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Manual No More: Automating the Scientific Data Lifecycle

whitePaper | May 23, 2022

The world’s scientific data today is a morass. 50-80% of research scientist and data scientist time is spent wrestling with data before they can focus on highervalue AI/ML and advanced analysis to help bring new life-saving therapeutics to market.

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Spotlight

FAMAR

Established in 1949 in Greece, FAMAR is one of Europe’s leading providers of Contract Manufacturing and Development Services to the Pharmaceutical and Health & Beauty industry.

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