Citizen Petition FDA


FDA stands for US Food and Drug Administration. This administration is subordinate to the United States Department of Health and Human Services. It is responsible for food, dietary supplements, pharmaceuticals, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary instruments and cosmetics. The aim of this department is to provide the highest quality products  for health and life. One of this way is Citizen Petition FDA.

What is a Citizen Petition?

Citizen petition is a type of petition written by American citizens to demand that existing practices be more beneficial to the total. So, Citizens submit this petition to the relevant administrations. With citizen petition, American citizens exercise their right to petition.

Citizen Petition FDA

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This kind of petition is the FDA’s most important guide to provide the highest quality products necessary for health and life. Citizens inform this adminstration about their opinions after they use the products. So, it is necessary for health and life in the society.

If any product has FDA approval; this means that its production conditions are suitable for health and it provides the promised effect. The reliability of the products without this certification should be questioned. You must submit the petition for questioning of such products.

How to Submit a Citizen Petition to FDA

If you don’t know how to submit a citizen petition to FDA, no need to worry because  you do not need professional help to submit this petition. You can easily create your petition for your own wishes and complaints with the FDA citizen petition sample.

FDA Citizen Petition Response Time

The FDA must respond to your petition within 180 days after you submit your petition. You can learn about the status of your petition from FDA officials. FDA response to citizen petition may be much earlier than 180 days or may be on day 179. Reasons such as conducting research on the petition and workload in the institution cause this period to be shortened or extended.

FDA Citizen Petition Tracker 

You can see the fda citizen petition tracker excel among the downloadable files in addition to the petition samples we share in our post. We hope that it would also help you in tracking your petition.

What You Need to Know About this petition?

The procedure for this type of petition is in Title 21 of the Code of Federal Regulations (21 CFR Part 10).

In 2016, US Pharmaceutical Research and Manufacturers requested several changes to the petition process, which the FDA denied. And, the updated  process in November 2016.

This practice aims to respond to citizens’ requests and complaints about medicine and food but pharmaceutical companies file many citizen petition against competing pharmaceutical companies.

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