FDA Database

Do you know anything about this FDA Investigator, or that FDA reviewer?
This is a question we get all the time!

When dealing with any government agency, especially one as large and important as the FDA, it is always a good idea to find out whatever you can about the FDA official you may be dealing with, whether it is an inspection, a 510(k) application, an ANDA or the new Food GMPs.

It is extremely hard to find this information anywhere and it is not available on the FDA website or for that matter, on the Internet.

Now it will be!

The new FDA Official Staff Information finder will be able to provide some insight into who you maybe dealing with.

  • Is the investigator – professional, easy to work with, or opinionated and difficult?
  • What is the investigator’s favorite inspection areas – process validations, analytical laboratory, batch records review?
  • Would you be able to speak with that reviewer during your submission process?
  • Was the reviewer responsive and his/hers questions and concerns valid?

With your help, the answers to these and other important questions will be in our new database.

We would like to know your dealing with all FDA officials, including your dealings with 510(k) submissions, Drug submission reviewers, compliance offices, investigator’s supervisors; district directors and any other FDA official you have dealt with.

We will be collecting this information on your experiences with the FDA and will then provide it exclusively to our members. By giving us your experiences and interactions with the FDA, we will give you a special membership to the database as a thank you for your help.

The FDA Official Staff Information DataBase will be the one place to find out what to expect when dealing with the FDA.

Fill out the FDA-DB questionnaire

You can fill out more than one questionnaire (1 for each FDA staff official you and your company has had dealings with).

!REMEMBER
This will be the only FDA OFFICIAL Staff Data to get the information you are looking for when searching FDA officials.