US FDA to increase misdemeanour prosecutions of pharma executives
This article was originally published in SRA
Executive Summary
Pharmaceutical and medtech executives responsible for assuring compliance with relevant US Food and Drug Administration regulations for products manufactured by their companies may face increased “misdemeanor prosecutions” if they fall short in their designated role.
You may also be interested in...
FDA's Beleaguered Criminal Investigations Unit Now Facing Congressional Scrutiny
After staff complain about becoming the 'Botox police,' a House committee is asking FDA for an update on two previous reports raising issues of management and morale in the Office of Criminal Investigations.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.