The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

For the past 20 years, the cost of new drug  development has risen at a rate  that was 7.4%  higher than inflation, and clinical trials bear...

The #1 Cause of Medical Device Recalls—and How to Avoid It

FDA report lists faulty software  design as top recall cause. by Lisa Weeks, MasterControl Communications Would it surprise you to learn tha...

The Past, Present and Future of CAPA

Conclusive CAPAs: Experienced market leaders  use detailed risk gateways like the one pictured  here to establish forward-looking, comprehen...

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

The FDA is working with a wide variety of  stakeholders  to identify  and promote practices  that will result in higher quality devices. by...

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

FDA has issued a draft guidance medical device  manufacturers should take to address cybersecurity risks. by Jason C. Gavejian, CIP P Princi...

CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of pa...

The FDA Just Called! Are You Ready for an Inspection?

If the FDA calls to schedule an  inspection, will you be prepared? by David R. Butcher Marketing Communications, MasterControl If the U.S. ...

How to Respond to FDA Inspection Observations, Including Those You Dispute

by Martin Browning, President, EduQuest, Inc.  FDA expert investigator and rule-maker for 22 years Although FDA is strapped with limited r...

Do You Really Want to Be An Executive In An FDA-Regulated Company?

If you don't want a visit from the  Department of Justice, pay attention  to the new enforcement policies  the DOJ is following. by Jam...

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most  complex pharma track and trace law ever passed. by David Dills Sr. Consultant, Regulatory ...

The Future of Medical Device Registries

 The FDA believes that national and international device  registries  in selected product areas are the foundation of  our National Medical ...

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic  master file (eTMF)  solution, be sure it  is versatile and not a one-trick pony! by Patricia Santos-Serra...

MasterControl to Serve as QMS Provider for Another FDA Division

The FDA’s CDER is responsible for ensuring drug  safety and effectiveness in the United States. by Cindy Fazzi Editor, MasterControl Insider...

FSMA: Get Inspection-Ready with These Best Practices

by Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group Although FDA immediately gained increased authority for records...

What Is a Food Safety Plan and What Is It Doing on My Table?

Would you like that burger with a side order of  food safety plan? If the restaurant doesn't  have one, you might want to reconsider you...

OMG! The FDA Is Keeping Up With Kim Kardashian, Too

The reality star promoted Diclegis on Instagram  without mentioning its side effects.  By Alex Butler, Product Manager, Life Science Applica...

FDA Requests Public Input on Quality Metrics Guidance

Which quality metrics are you tracking  for audits and inspections?  The FDA is seeking input  on the types of data that contribute to a ...

Infographic: FDA Inspections By The Numbers

During the last 15 years, FDA has gradually  ramped up the number of annual inspections. by Tony Chen CEO and Co-Founder of FDAzilla Up un...

Unique Device Identification (UDI): Much More Than Just a Label

Unique device identification (UDI) will not only change  the face of your med device labels, but it will  also affect processes spanning y...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...