Basics on the FDA: The FDA is a U.S. government agency with authority to regulate food, drugs, medical devices, cosmetics, livestock feeds, pet foods, and tobacco products. The FDA web site is at www.fda.gov, and phone numbers are available through the Contact page.
FDA documents not available on the FDA website can often be purchased from FOI Services. These include:
- Petitions (Citizen Petitions, Food Additive Petitions, Color Additive Petitions);
- Drug Approval Letters, Package Inserts and Labeling, FDA Final Reviews and the Summary Basis of Approval (SBOA);
- Medical device documents including 510(k) Notifications, Pre-Market Approval Notifications (PMA Notifications), Medical Device / Adverse Reaction Notifications;
- Inspection Reports (EIRs, 483s, warning letters and related correspondence),
- Guidelines and Guidance Manuals, Advisory Committee Meeting minutes and transcripts, etc.
Drug Approvals: New drug approvals are posted on the New and Generic Drug Approvals page of the FDA website. They are also reported in Pharmaceuticals Approvals Monthly and Scrip Intelligence.
If you subscribe, the Mediregs Pharmaceutical Regulation Suite (information available here) has an extensive searchable collection of FDA materials including drug approvals (archived back to 1996, plus a list of older approvals with Submission Tracking Numbers or STNs).
Drug Approval Processes: The FDA generally will not disclose or even confirm the filing of an application for approval of a new drug until and unless the drug is approved. Once a drug is approved, the FDA posts selected materials from the approval process. To find that material:
- Look up the name of the drug in the Drugs@FDA database
- Click the link for
- Scroll down to the "Approval History" section
- The available materials will be linked from the line that says "Approval."
The FDA generally does not disclose the original application or the scientific material filed support application. You may be able to get these materials or additional materials by filing a FOIA request.
The information that can be disclosed for "Investigative New Drugs" (INDs) is governed by 21 CFR 312.130. Subsection (b) cross references 21 CFR 314.430 for the specifics of what information can be disclosed for drugs.
Form 483s: After the FDA inspects a facility, the inspector fills out a Form 483 listing his or her "observations." This can give you an idea of what FDA inspectors are looking for. For more about 483s, see the FDA's 483 FAQ. A list of 483s back to 2000 is posted on FDAzilla's
FDA Inspections/483s Dashboard
A few 483s are posted free in the ORA FOIA Electronic Reading Room. Otherwise, you can get 483s by filing a FOIA request with the FDA (free but slow), or you can purchase them from FOI Services, 483sOnline.com (by FDANews) or the 483 Store.
Orange Book: For information about the list of Approved Drug Products With Therapeutic Equivalence Evaluations, see the Orange Book entry.
Warning Letters: The FDA posts "general" Warning Letters on their Inspections, Compliance, Enforcement, and Criminal Investigations page (1996-present). The FDA also posts Tobacco Retailer Warning Letters (from the last 45 days) and Untitled and Warning Letters to Pharmaceutical Companies sent to pharmaceutical companies (1997 to present). For searching, you can use:
- the FDA's Warning Letters Advanced Search
- the Food, Drugs and Devices library on CCH Intelliconnect for general Warning Letters (1996 to present) but not the Untitled and Warning Letters to Pharmaceutical Companies (subscription only)
- the Pharmaceutical Suite MediRegs, which has general Warning Letters (1990-present), "Cyber" Letters (2000-present) and Untitled and Warning Letters to Pharmaceutical Companies (1997-present) (subscription only)
- Thompson's online FDA Enforcement Manual [which may now be part of their Compliance Expert product] (subscription required).
Warning letters are summarized in the Warning Letter Bulletin.