EIRs Full Text!Click here to search inspection documents FULL TEXT!
Searching is free.
You can already search the descriptions of all of FOI’s records…and now, you can search the full text of EIRs, 483s, FDA/Industry correspondence and other inspection-related content for revealing and hard to find information:
Enter your keyword(s) to search the
The Freedom of Information Act (FOIA) requires U.S. agencies to disclose many of their records. FDA's FOIA records usually aren't on the agency website – they're files from the desk drawers of reviewers, investigators, and other officials - and FOI Services has collected over 100,000 of these documents. Contact us at infoFOI@foiservices.com for more information.
Find a Document You Need?
Add it to your cart and download it immediately.
Want Some Advice?
Contact us...our information specialists can explain document
content, help you search, and answer other questions.
Can't Find Something?
Call us at +1-301-975-9400 to place a custom request.
FDA Orphan Drug Review
In this November 2018 document, the US General Accountability Office evaluates the consistency of FDA's orphan drug designation reviews and explores other challenges in development of drugs for rare diseases. Contents address FDA's plans for modernization of orphan designations, criteria used to grant orphan status, timelines and rates of product review, and the guidance and training developed to address development issues.
Featured until February 26, 2019. Click here to download.