FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness Evidence

Posted on August 2016 by Frank J. Sasinowski and Alexander J. Varond

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To purchase articles, go to https://shop.heinonline.org/.   Table of Contents i Reports to the Reader 481 ...read more

The 340B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety ne...read more

The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that misconduct is widespread and even risks slipping into the banalitie...read more

Within the last few decades, a shift has taken place in FDA’s approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing...read more

The right to food is an internationally recognized human right, which inherently denotes the right to safe food simply because unsafe foods cause different diseases resulting in consumer’s di...read more

The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy and quality issues. At the same time, public interest in these innovative therapies ...read more

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recently, there is renewed interest; personalized medicine is much...read more

This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transparency Initiative and a reduction in the agency’s FOIA b...read more

The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation se...read more