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FDA
Former FDA Commissioner Calls for Updated Systems and More Education for…
Former Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., recently wrote an op-ed in the Wall Street…
FDA Advisory Committee Vacancies and Interests
Advisory Committees at the Food and Drug Administration (FDA) are receiving a lot of attention lately. Most of the concerns…
Increasing Generic Drug Shortages Linked to Government Price Controls
As we previously noted, the Food and Drug Administration (FDA) recently released guidance to industry regarding the reporting of…
FDA: FDAA DTC Television Ad Pre-Dissemination Review Program
Over the past few years, Congress and media have paid increased attention to direct-to-consumer (DTC) television advertisements…
FDA: Guidance for Sponsors, Investigators, and Institutional Review Boards
Earlier this month, the Food and Drug Administration (FDA) released a new Clinical Trials Guidance Document. The guidance…
FDA Guidance Notification of Prescription Drug or Biologic Product Drug…
There have been significant media coverage and government oversight surrounding drug shortages over the past few months. On…
FDA Clarifies the Three Biosimilars Draft Guidance’s
The Food and Drug Administration (FDA) presented an educational webinar on biosimilars, and provided an overview of the law, the…
FDA Distraction Study – Shows No Distractions After All
Almost two years ago, the Food and Drug Administration (FDA) issued proposed guidance for direct to consumer television (DTC) and…
FDA Using Accountability to Deter Illegal Marketing Activity
Using accountability as a tool to deter illegal activity like misbranding and promote corporate transparency was a resounding…
FDA CDRH – MDUFA Agreement and Strategic Priorities for 2012
The FDA and industry recently came to an agreement in principle for the Medical Device User Fee Act (MDUFA), costing the device…