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

Pharmacogenomics is the branch of pharmacology which looks at the influence of genetic variation on drug response, connecting particular genetic markers with the effectiveness or safety of a drug. ...read more

Social media marketing is the next frontier for direct-to-consumer advertising of pharmaceutical products, but represents an unchartered territory for regulatory action. With explosive growth in th...read more

A Drug Enforcement Administration (“DEA”) registration is not only a necessity, but also an invaluable commodity for doctors, pharmacists, hospitals and drug wholesalers who prescribe, ...read more