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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New Haven Pharmaceuticals, Inc.

New Haven Pharmaceuticals unites industry-leading experience with data-driven insight. By applying contemporary metadata analysis to large volumes of medical information, New Haven Pharmaceuticals is able to create new solutions and significant health benefits while leveraging knowledge gleaned from decades of clinical knowledge about highly regarded drugs.

OTHER WHITEPAPERS
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Drug Solubility and the Need for Speed

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

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Redefining the Role of Health Systems as a Specialty Pharmacy Solution for Drug Manufacturers

whitePaper | January 10, 2023

The ideal care model for complex patients is a model in which the entire health care team is made up of experts in the specific disease state being treated. Integrated health care systems and major academic medical centers provide this level of expertise and coordination.

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Deck 7 Webinars and Virtual Events

whitePaper | January 1, 2020

If you recognize some of these challenges, download the Deck 7 Webinar & Virtual Events overview to see how we make it easy for busy marketers to run highly successful webinars and virtual events....

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THE PHARMACEUTICAL INDUSTRY AND GLOBAL HEALTH

whitePaper | January 31, 2022

COVID-19 is an infectious disease caused by a newly discovered coronavirus, which was first identified in December 2019.

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The Ultimate Guide to Digitizing Pharma Manufacturing

whitePaper | September 15, 2022

The sheer size of the pharmaceutical industry makes it important for all stakeholders to stay up to date with pharmaceutical industry trends.

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Winning with biosimilars Opportunities in global markets

whitePaper | March 14, 2022

Over the past several years, biologics have gained significant traction in the pharmaceutical industry, representing more than $150 billion in global sales in 2013. By 2020 they are predicted to generate $290 billion in revenue and comprise 27 percent of the pharmaceutical market.i

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Spotlight

New Haven Pharmaceuticals, Inc.

New Haven Pharmaceuticals unites industry-leading experience with data-driven insight. By applying contemporary metadata analysis to large volumes of medical information, New Haven Pharmaceuticals is able to create new solutions and significant health benefits while leveraging knowledge gleaned from decades of clinical knowledge about highly regarded drugs.

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