FDA Clinical Trial Compliance Guide – New Study Requirements?


The process of getting a drug approved is long, strenuous, costly, and difficult. New drugs can take anywhere from 6-11 years to approve.

To avoid setbacks and one of the best things that clinical investigators, site managers, regulatory affairs staff, research and development teams, and lab managers can do is to have the right information on hand. In doing so, those looking to get new drugs approved will have an easier time.

To date, the FDA has issued “more than 100 guidance documents” that identify information such as the Animal Rule and the right validating software to use in studies. While individuals can certainly go through the paper text versions of the documents, the process has now gotten so much easier.

About the FDA Clinical Trial Compliance Guide

Recently, the FDA has released its online version of the documents, complied into one neat product called FDA Clinical Trial Compliance Guide. This guidebook features the “FDA’s most crucial guidances on clinical research.” The management reports included in this guide cover the following topics:

  • The components of an FDA inspection
  • Compliance rules for in-vitro diagnostic devices
  • The reporting process for events adverse to an IRB
  • The process of establishing and operating data monitoring committees
  • Responding to investigator misconduct
  • Requirements for Investigational New Drugs (IND) and Investigational Device Exception (IDE)

In addition, the FDA Clinical Trial Compliance Guide also features information about trial sponsors, medical devices, trial management, investigators, GMP/GCP, HDEs and HUDs, electronics and software, data management, biologics, and international conference on harmonization.

FDA Clinical Trial Compliance Guide Conclusion

Those who are interested in viewing a sample of this compliance guide can do so through the FDANews website. The sample provides an ample amount of insight so that interested individuals know what to expect.

Further, the guidebook comes in a completely searchable format. This way, those who purchase the guide do not need to spend hours looking through it. The PDF version is currently priced at $397 and downloads immediately upon ordering.

Supplement Police
Supplement Policehttps://supplementpolice.com/
Affiliate Disclosure: For full FTC compliance transparency; please assume we may receive a small commission from the sales of certain products & supplements reviewed. In order to operate optimally, our dedicated team & site is supported by advertising revenue and can be compensated from recommended product links.


Please enter your comment!
Please enter your name here


Affiliate Transparency:

With full FTC compliance disclosure, please know our goal is to highlight human health and develop strategic partnerships with a variety of seasoned supplement suppliers affiliate compensation notice and new wellness product creators from around the world. Our intention is to organize optimal outlets for you, we may receive small commissions from providing links and sharing ads. The team has your best interest at hand, we care as much about your health as you do and that’s why you’re reading this. Want to learn more?