FDA

Earlier this month, the Food and Drug Administration (FDA) released a new Clinical Trials Guidance Document.  The guidance…

There have been significant media coverage and government oversight surrounding drug shortages over the past few months.  On…

The Food and Drug Administration (FDA) presented an educational webinar on biosimilars, and provided an overview of the law, the…

Almost two years ago, the Food and Drug Administration (FDA) issued proposed guidance for direct to consumer television (DTC) and…

Using accountability as a tool to deter illegal activity like misbranding and promote corporate transparency was a resounding…

The FDA and industry recently came to an agreement in principle for the Medical Device User Fee Act (MDUFA), costing the device…

The Food and Drug Administration (FDA) recently announced the availability of a draft report entitled “Quantitative Summary of the…

The U.S. Food and Drug Administration (FDA) last week announced that it had completed its recommendations for three user fee…

The Food and Drug Administration (FDA) recently approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the…

The Offices of Regulatory Policy, Medical Policy, Surveillance and Epidemiology, New Drugs, Compliance, and Generic Drugs in the…