The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

Posted 20 February 2015 | By Alexander Gaffney, RAC 

The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost encyclopedic knowledge of the regulator's website to find relevant information, to say nothing of the dozens of other government websites which house regulatory information or non-governmental websites which make finding information easier.

What if there were an easier way to find the FDA-related information you're looking for?

Now there is. Regulatory Focus has assembled this list of the most important FDA webpages, government websites and non-governmental websites, all in the hopes of making FDA-related information easier to find.

This page is intended to assist anyone interested in FDA, including regulatory professionals, journalists, academics, patients, healthcare providers and stock traders.

FDA Websites
Website/Web Page Synopsis
Guidance Database Searching for an old guidance document, or just trying to see if FDA has posted any new guidance? FDA's new unified guidance document database is a must-bookmark page.
Regulations.gov All of FDA's regulatory documents, including public correspondence with FDA, is posted to the Regulations.gov website.
Federal Register Find out when FDA has posted a new guidance document, regulation, call for comment or meeting notice by following the agency's Federal Register page. You can also get the information a day in advance through its Special Filing page.
Drug Innovation FDA's webpage for listing all new and innovative pharmaceutical products approved by the agency.
FDA Email Update List One of the easiest ways to find the latest FDA information is to have it delivered to your email as soon as it's new. Sign up for nearly all of FDA's email-based alerts here.
Press Announcements If it's new and important at FDA, changes are good the agency will publish a press announcement about it. Keep track of the latest announcements here.
FDA Voice Interested in knowing more about not just what FDA is doing, but why? Check out FDA's "Voice" blog, which features posts from many of its most influential regulatory officials.
Import Alerts Is a company in trouble with FDA? You can often find out first by seeing if it's subject to an import alert, which are posted to FDA's website here.
Enforcement Reports FDA's webpage containing weekly reports of all recalls occurring in a given week.
FDA Warning Letters FDA's webpage where it posts its most recent Warning Letters. Updated every Tuesday morning, with rare updates on other days as well.
Drug Trials Snapshot FDA's webpage for explaining clinical trials data used in the approval of new medicines, and in particular the demographic breakdown of each trial.
FDA Data Dashboard A new web tool which allows the public to see high-level data about FDA's inspections and other enforcement data.
OpenFDA FDA's new active programmable interface (API)-driven website. Provides information about adverse events, drug and device labeling, enforcement events and more.
Notice of Violation Letters FDA's letters to companies regarding their promotion of approved drug products is posted to this webpage.
FDA-TRACK Doing research on FDA performance? The agency's FDA TRACK webpage has a wealth of information hard to obtain anywhere else.
Drug Approvals and Databases FDA's pharmaceutical reviewers maintain a helpful list of all approved products and databases used to keep track of drug regulation information.
Drugs@FDA If drug approvals are of interest to you, FDA's Drugs@FDA database should be in your bookmarks tab. Find the latest new drugs, generic drugs and label updates here. You can also find the approved labels and study data for most approved products.
FOIA Documents If FDA gets repeated requests for certain documents, it will often post those documents to its website on a page known as its "electronic reading room."
Mini-Sentinel FDA's product surveillance system tracks tens of millions of patients, and is in the process of becoming a full-fledged surveillance network.
Medical Device Databases FDA's medical device review division maintains a handy page containing links to all of CDRH's various databases, of which there are more than a dozen.
Biologics Products & Establishments FDA's biologics review division also maintains a helpful list of all of its approval and oversight databases.
FDA Advisory Committees FDA Advisory Committees are hugely influential to the approval of new products, even if their advice isn't necessarily binding. This FDA webpage links to pages for all of its committees, including documents from previous and upcoming meetings.
Orphan Drug Designations and Approvals Rare diseases are defined as affecting fewer than 200,000 persons in the US, and drugs approved to treat them are given 7 years of market exclusivity. Find out which drugs are eligible for that special status here.
Orange Book Ignore the weird title—FDA's Orange Book contains essential information about drugs and their generic equivalents. If you're looking for information about generic drugs, this is the publication you want to read.
CDER – What's New? FDA's Center for Drug Evaluation and Research (CDER) is large enough that it generally posts several new items to its website every day. All of those items are listed here.
Past Meetings With FDA Officials Has FDA recently met with a trade group, attended a conference or conversed with a company about a regulatory issue? Find out at this webpage.
FDA Staff Directory Need to find the contact information for an FDA staff member? All of the details are available online at the US Department of Health and Human Services' Website.
FDA Media Contacts If you work in the media and need to contact the agency about a particular topic, use this page to find out who you should contact.
Non-FDA Websites
ResearchAE A private site leveraging FDA's openFDA APIs. Easy-to-find information about drug recalls, safety problems, approvals and more.
NIH's ClinRegs The NIH's extraordinarily ambitious attempt to keep track of global clinical trial requirements and make them easy to understand and compare.
ClinicalTrials.gov Looking for results from a specific clinical trial? Want to know if there are new clinical trials affecting a specific disease? The NIH's clinical trials database, ClinicalTrials.gov, is a one-stop shop for trials information.
Unified Agenda Each year, all regulatory agencies are required to post a list of the regulatory actions they intend to take during that fiscal year. That list is known as the Unified Agenda, and is posted online.
OIRA Most of FDA's regulations and guidance get reviewed by the Office of Information and Regulatory Affairs (OIRA) before they can be made final. Find out which documents are currently under review at OIRA's website.
Grants.gov Want to know what FDA cares about? Find out what it's funding at the grants.gov website.
Clinical Study Data Request Did you know most major US pharmaceutical companies will allow you to look at the clinical data used to approve new drugs? If you're a researcher, use this site to submit a request to access that data.
Congress.gov FDA, like every bureaucratic institution, is affected by Congress and the legislation it introduces. Keep track of the latest legislation on Congress.gov by setting specific search parameters.
White House Are FDA officials meeting with the White House? Find out on the White House's EO 12866 meetings search page.
RegData How many regulatory requirements does FDA enforce? Find out with this handy tool for the Mercatus Center.

Page last updated on 20 February 2015. Is a link on this page broken? Are we missing an important website or webpage? Let us know! Email us at news@raps.org and we'll try to make an update as soon as possible.


Categories: Regulatory News, Trackers

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe