FDA Complete Response Letters

Data through 7 August 2026.

Complete response letters

445

Newest letter

7 August 2026

openFDA last updated

13 August 2026

For applications since approved

297

For applications not approved

148

Source: the openFDA transparency endpoint for complete response letters, read at build time and refreshed at most daily. Counts cover complete response letters only. Headings are FDA's own section headings, counted from the scanned text of each letter, with standing sections such as prescribing information left out; they are approximate, and a letter can carry several.

A complete response letter (CRL) is FDA's decision that it will not approve a drug or biologic application in its present form. The letter lists the deficiencies the sponsor has to address. For new drug applications the rule is 21 CFR 314.110, and for biologics license applications it is 21 CFR 601.3. The glossary entry explains the regulation and what follows a CRL.

FDA did not used to publish them. That changed in July 2025, when it released more than 200 letters for products that had since been approved. In September 2025 it added 89 more for applications that were unapproved, pending or withdrawn, and said it would release future letters promptly after issuing them. FDA keeps the dataset on openFDA as a centralized database of complete response letters. It also says it may add batches from its archives for withdrawn and approved applications.

This tool searches that dataset, including the full text of every letter. The dataset holds a few other letter types, such as tentative approvals and refuse-to-file letters. The search leaves them out and counts only complete response letters.

Company name

The sponsor the letter is addressed to, as FDA wrote it. Sponsors change names and appear under more than one.

Application number

NDA, BLA or ANDA with its number. A letter can name more than one. Each result links to the application's Drugs@FDA record where the number allows.

Letter date and year

The date on the letter. FDA publishes it as MM/DD/YYYY, and the tool shows it as a day, month and year.

Approval status

Approved or Unapproved. It describes the application at the time FDA released the dataset, not the letter: a CRL for an application that was later approved is marked Approved.

Company representative

The named person the letter is addressed to, taken from the letter. It is scanned text, so names are sometimes garbled.

Review division

The FDA office that signed the letter, where the scan makes it legible.

Deficiency headings

FDA's own section headings from inside the letter, such as FACILITY INSPECTIONS or PRODUCT QUALITY. The tool lists the ones that vary and hides the standing sections.

Letter text

The full body, read from a scanned PDF by optical character recognition. Searchable here. FDA redacts confidential commercial information before release.

• By text in the letter. The first field searches the whole body. A phrase finds every letter that uses it, for example aseptic processing, bioequivalence or a named impurity.
• By company. Part of a name is enough. Try a short form of the sponsor's name.
• By application number. Enter it as NDA 218705 or BLA 761234 to get that application's letters.
• By year. A four-digit letter year. Combine it with text to see how a topic changed, for example facility in 2025.

Fields combine, and a letter has to match every field you fill in. Results come back newest first, 20 to a page, and the address bar updates so any search can be linked.

Every CRL says the same thing at the top: FDA has completed its review and has determined that it cannot approve the application in its present form. The reasons follow, usually under capitalised headings. Read the headings first.

• Clinical or statistical. The efficacy or safety evidence is not enough. FDA may ask for a new trial or for more analysis of the data submitted.
• Product quality. Chemistry, manufacturing and controls problems: specifications, stability, validation, the drug substance or product.
• Facility inspections. An inspection of a manufacturing or testing site found issues, or the site could not be inspected. These are the most common headings in the published letters.
• Labeling and other. Prescribing information, carton labeling and similar sections appear in most letters as standing items and rarely explain the outcome.

The letter ends with the sponsor's options. For a new drug application the sponsor can resubmit, withdraw, or ask for an opportunity for a hearing. For a biologics application it can resubmit or withdraw, and no hearing option exists. If the sponsor does nothing within a year, FDA may treat that as a request to withdraw. The deadline can be extended on request. These rules are in the regulations cited above.

We counted the headings across the corpus in the most common reasons for complete response letters, including how often manufacturing and clinical problems appear.

For reasons by year and which applications were approved after a letter, read why FDA issues complete response letters.

• It is a subset. FDA has published letters that it chose to release, from 2025 on, plus its archive batches. Sponsors have received CRLs that are not here.
• It lags. The data block above shows the date of the newest letter and when openFDA last refreshed the dataset. Letters FDA published since then are missing.
• The text is scanned. OCR errors, garbled names and redaction gaps are common. Read the letter itself before quoting it.
• Headings are not conclusions. A heading shows what a section covers, not how FDA weighed it. Read the section.
• It says nothing about what happened next. Whether the sponsor resubmitted, how long it took, and the later outcome are in Drugs@FDA and company disclosures, not in the letter.
• Application numbers can be mis-scanned. Some BLA numbers read as BL instead, which undercounts biologics if you filter on the prefix.

The openFDA API. The endpoint is https://api.fda.gov/transparency/crl.json. A search for one company looks like ?search=company_name:"Apiject"&limit=5, and the letter body is searchable with text:"stability". Without a key openFDA allows 240 requests a minute and 1,000 a day per IP address, and a free key raises the daily limit to 120,000.

Bulk file. openFDA publishes the whole dataset as a single zipped JSON file of about a megabyte at download.open.fda.gov. It is the fastest way to run your own analysis.

FDA's table. FDA's CRL table lists the letters and searches by company name.

What is a Complete Response Letter?

FDA's decision not to approve an application in its present form, issued under 21 CFR 314.110. It lists the deficiencies the sponsor must address before the application can be approved.

Are FDA Complete Response Letters public?

Increasingly. FDA began publishing them in 2025, starting with roughly 200 letters and adding more since, with a stated commitment to publish them promptly after issuance.

How many CRLs are published?

The openFDA transparency dataset holds several hundred complete response letters. The data block on this page gives the current count and the date of the newest letter. This tool searches all of them, including the full letter text.

What do the deficiency tags mean?

They are FDA's own section headings from inside each letter, such as FACILITY INSPECTIONS or PRODUCT QUALITY. Standing sections that appear in nearly every letter, like PRESCRIBING INFORMATION, are hidden so the meaningful ones stand out.

Can I search the text of the letters?

Yes. The first field searches the full letter body, so you can find every letter mentioning aseptic processing, stability or a specific impurity.

How often is the CRL database updated?

FDA says it adds letters as they are issued. openFDA refreshes its copy on its own schedule, so this page shows the date of the newest letter in the data and when openFDA last updated it. Letters published since then are not here yet.

Is there an API or bulk download for complete response letters?

Yes. The openFDA endpoint is api.fda.gov/transparency/crl.json, and the whole dataset is also published as one zipped JSON file of about a megabyte at download.open.fda.gov. openFDA limits requests to 240 a minute and 1,000 a day per IP address without a free key.

Is this data official?

It comes directly from FDA's openFDA transparency API, and each result links to the application's Drugs@FDA record. The letters are OCR'd from scanned PDFs, so some fields are imperfect.