Pressure Mounts for Patient Access to Investigational Drugs

Regulations allowing compassionate use of investigational drugs have been in effect since 1987, when public anger about the slow pace of approvals for HIV/AIDS drugs resulted in rules allowing greater access to drugs in development. Last year, the FDA updated its rule to expand the patient categories that may have rights to use unapproved drugs and to clarify requirements for expanded-access programs. The old system allowed individual patients access to investigational drugs through an emergency IND system, while large groups received access through treatment protocols. Under the new rule, the FDA allows access to unapproved drugs on a case-by-case basis for single patients, small groups of patients with similar treatment needs and even larger groups of 100 patients or more. In addition, the term “serious illness” has been redefined to include a much broader array of conditions.

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North Spring Behavioral Healthcare

Children and families are the center of everything we do. North Spring Behavioral Healthcare offers children and adolescents a continuum of care that includes inpatient and outpatient services to address a variety of psychiatric and behavioral needs.

OTHER WHITEPAPERS
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Prescription Drug Pricing: How Lack of Transparency Reduces Market Access, Utilization, and Adherence

whitePaper | November 25, 2019

It's clear that healthcare prices weigh heavily on the minds of Americans, and the time has come for the pharmaceutical industry to take the reins of the prescription drug pricing dialogue with consumers.

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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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Blockchain technology in the pharmaceutical industry

whitePaper | March 11, 2022

Blockchain technology is accelerating digital transformation across multiple industries, including the pharmaceutical industry.

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Choosing the Right Temperature Monitoring Solution

whitePaper | April 24, 2023

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other temperature‐sensitive products are commercialized for a global clientele. Many regulators now recommend including temperature monitoring technology in every cold chain shipment.

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Application Notes & Whitepapers 2019

whitePaper | December 19, 2019

Welcome to European Pharmaceutical Review’s Application Notes & Whitepapers Supplement 2019. This year’s topics range from analytical techniques for bioprocess investigation, host cell protein analysis and Raman imaging to advice on outsourcing services for product characterisation.

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Protein fingerprints pave the way for microarray comparison

whitePaper | June 9, 2022

Anaxomics has developed a novel method of analysis for microarray data based on the generation and subsequent comparison of 2D fingerprints for each sample. Microarray results are incorporated into a protein interaction network and embedded with all sorts of biological and medical data.

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Spotlight

North Spring Behavioral Healthcare

Children and families are the center of everything we do. North Spring Behavioral Healthcare offers children and adolescents a continuum of care that includes inpatient and outpatient services to address a variety of psychiatric and behavioral needs.

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