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 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

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United State...read more

The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of unsafe or ineffective medicines in the United States. Perha...read more

The Supreme Court’s decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a “plausible” claim to relief before they can access d...read more

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown University partnership we feature Georgetown University Law...read more

The statute and regulations administered by the Food and Drug Administration (“FDA”) do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the g...read more