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2 Year - U.S. Regulatory Reporter Newsletter for International Addresses Outside of Europe

- $890.00

No other publication monitors the FDA offices and divisions that review your products more closely than the U.S. Regulatory Reporter. We give you a steady flow of hard regulatory information, one-on-one interview with CDER's review division directors, the latest regulatory statistics, and in-depth analysis on emerging issues and processes associated with drug development and approval.

In each monthly issue, the U.S. Regulatory Reporter provides the information you need to benchmark your own regulatory activities, and to gear your regulatory strategies to address emerging FDA issues and concerns.

From IND reform to regulatory performance benchmarking, and from accelerated drug review case studies to ANDAs, the U.S. Regulatory Reporter gives you the issues before they become issues. Each month, you'll be brought face-to-face with the people and issues most critical to you and your company's products.

Includes 2 year subscription and shipping costs to international addresses outside of Europe.


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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

GCP for Investigators

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

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BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

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Blended Curriculum Path for the CRA, CRC, and Project Manager

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Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)