Online Safety Community

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products

The FDA's requirements for non-IND Foreign Clinical Studies 2https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-fdas-requirements-for-non-ind-foreign-clinical-studies-2.jpg?w=800&h=504 800w, https://globalcompliancepaneltraining.files.wordpress.com/2017/12/t... 150w, https://globalcompliancepaneltraining.files.wordpress.com/2017/12/t... 300w, https://globalcompliancepaneltraining.files.wordpress.com/2017/12/t... 768w" sizes="(max-width: 400px) 100vw, 400px" width="400" height="252" />

that are permitted under this system of foreign clinical studies include:

  • A human drug
  • A biological drug
  • A medical device

The guidelines for foreign clinical studies requirements

The guidelines under which the FDA accepts medical products for approval when they are the result of foreign clinical studies are spelt out in various sections of 21 CFR.

Any foreign clinical study has to be meet requirements of 21 CFR Part 312or 21 CFR Part 812, which relate to studies conducted under an Investigational New Drug Application (NDA) or Investigational Device Exemption (IDE) respectively, just the same way in which American companies too have to

In case a foreign clinical study is not conducted under an IND; the FDA will still accept it, so long as it fulfills the ethical principles set out in the Declaration of Helsinki, or is in accordance with the laws of the respective country from which the study originates, based on whichever of these two offers stronger protection of the subjects of the study.

Highlights of the Helsinki Declaration

The FDA's requirements for non-IND Foreign Clinical Studies 1https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-fdas-requirements-for-non-ind-foreign-clinical-studies-1.jpg?w=762&h=540 762w, https://globalcompliancepaneltraining.files.wordpress.com/2017/12/t... 150w, https://globalcompliancepaneltraining.files.wordpress.com/2017/12/t... 300w" sizes="(max-width: 381px) 100vw, 381px" width="381" height="270" />

The World Medical Association adapted the Helsinki Declaration from the time it was passed in 1964. In 1975, given the popularity of the Declaration in guaranteeing humane protection of human subjects in a clinical study; the FDA adapted the principles of the Helsinki Declaration as the basis for accepting non-IND compliant drugs. This Declaration has been revised a few times, although the FDA is yet to include the latest of these, that of October 2000, into its regulations.

Points of significance

Views: 42

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Simon Hopes posted a blog post

Speed governor is a technical invention

The popularity of Watt's improved steam engine was rapid, and by 1790 the old Newcomen steam engine was out of sight, and by 1790 there were about 500 steam engines operating in Britain. After less than 100 years or so, by 1868, there were as many as 75,000 steam engines in Britain alone. In 1805, the steam engine in the United States was equipped with cars as a driving force. In 1807, Robert Fulton (1765-1815) of the United States invented a steamship powered by a steam engine. In 1825 George…See More
20 hours ago
HrishikeshRam posted blog posts
20 hours ago
Russel Stuart posted a blog post

HR Documentation is a Vital Aspect of Organizations

HR documentation is of vital importance to organizations. Unless its nuances are mastered organizations can fall into embarrassing and damaging pitfalls.HR documentation is one of the most important aspects at the workplace. The habit of HR documentation is usually imbibed into HR professionals from early on in their careers. But what does HR document?HR documentation resonates with the spirit of the dictum, Verba volant, Scripta manent, meaning "what is written stands; what is uttered flies".…See More
yesterday
Laticia Gibson posted a blog post

Searching A Best Dental Clinic Is Important

Keeping a perfect oral health is crucial. Though, in keeping good teeth set, always it has been a must to research for the good General Dental office you can find in your nearby area. It has to be noted that searching the most suitable clinic can confirm you of good quality and pleasing services. Earlier than you make a selection, there are some important things you have to know.The Crucial Things to…See More
Friday

Forum

Road Safety

What can be the best measures for Road Safety?Continue

Started by Jen McDade Sep 27.

safety equipments in breweries 4 Replies

safety equipments in breweries -- kindly provide detailsContinue

Started by ajit. Last reply by Jen McDade Sep 24.

Unusual Safety Tips 10 Replies

Please share some unusual but genuine safety precautions.My unusual safety tips - Don't drink sweet fruity juice while driving in the night as it contains sugar and sugar slows down your blood…Continue

Started by Arnold Brame. Last reply by Jen McDade Sep 24.

Safety products 9 Replies

While working or at some work stations, employees are exposed to threats or at times suffer severe injuries. The safety of the employee should be the foremost priority. Safety equipment aids help in…Continue

Tags: equipments, and, products

Started by Enna Henry. Last reply by Jen McDade Sep 24.

Talend Application Integration

APPLICATION INTEGRATION:Talend ESB and Application Integration delivers agile real-time integration of applications and data.Heterogeneous Application and Data IntegrationTalend’s open source ESB…Continue

Tags: york, new, certification, training, talend

Started by nicolewells Sep 21.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service