ARTICLES BY CYNTHIA SCHNEDAR
Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?10/27/2020
The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.
An Analysis Of The FDA’s Drug Shortages Root Cause Report12/27/2019
In Oct. 2019, the FDA's Drug Shortage Task Force published a report that identified root causes of drug shortages across the U.S. healthcare system and made recommendations for effectively resolving those underlying issues. This article summarizes the report's findings and discusses potential next steps the FDA may take.
What Does IMDRF’s New Cybersecurity Guidance Mean For You?12/2/2019
Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.
New FDA Powers Under The SUPPORT Act — What Pharma Manufacturers Need To Know12/19/2018
Drug manufacturers should be aware of new regulatory powers given to the FDA in a recently enacted law aimed at deterring opioid abuse. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) became law on Oct. 24, 2018 with bipartisan support in both the House and the Senate.
The FDA/EU Mutual Recognition Agreement — What You Need To Know12/7/2017
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.
Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports12/9/2016
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.
5 Steps To Build A Quality Culture That Supports Data Integrity9/20/2016
When it comes to building a culture of quality, many companies ask, "Where do we start?” For those looking to instill good practices that will ensure the integrity of data, there are a wealth of recent resources to review.