Research · 11 min read
What FDA Publishes When It Approves a Drug
On the day an approval letter goes out, a defined list becomes immediately public — including FDA's own summary of the evidence and all correspondence with the company. Three categories never become public at all, and one of them is how the drug is made.
Key takeaways
- Before an approval letter, FDA will not disclose even that an application exists unless that has already been publicly acknowledged.
- Approval makes a defined list immediately public, including a Summary Basis of Approval and all FDA-to-applicant correspondence about the application.
- The published summaries are expressly not the full reports of investigations the approval rests on.
- Manufacturing methods and quality control procedures, production and sales data, and quantitative formulas stay private.
- A discretionary carve-out lets the Commissioner release a summary of selected data for a pending issue such as an open advisory committee session.
- A complete response letter lists all specific deficiencies FDA identified and, where possible, recommends actions to fix them.
- A resubmission restarts the clock at two or six months depending on classification, and a year of inaction can be treated as a withdrawal request.
- Drugs@FDA is searchable by drug name, active ingredient or application number, and the application number is the most precise of the three.
Answer first: approval flips a switch
Before an approval letter is sent, the default is silence. FDA will not publicly disclose even the existence of an application, unless the existence has already been publicly disclosed or acknowledged. And where the existence of an unapproved application has not been disclosed, no data or information in it is available for public disclosure at all.
After FDA sends an approval letter, a specific list becomes immediately available for public disclosure, unless the applicant shows that extraordinary circumstances exist.
The centerpiece of that list is a document called a Summary Basis of Approval — a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process.
Alongside it sit five more categories. Protocols for tests or studies. Adverse reaction and product experience reports with identifiers stripped. The list of active ingredients. Analytical procedures. And all correspondence and written summaries of oral discussions between FDA and the applicant relating to the application.
That last item is the one people underestimate. The back-and-forth between an agency and a company about an application does not stay private once the drug is approved.
The window before approval, and the advisory committee exception
The rule sets out three states, and knowing which one an application is in tells you what can exist publicly.
State one: the existence of the application has not been disclosed. Nothing in it is available.
State two: the existence has been disclosed or acknowledged, but no approval letter has been sent. No data or information in the application is available before that letter — with one carve-out.
The Commissioner may, at his or her discretion, disclose a summary of selected portions of the safety and effectiveness data that are appropriate for public consideration of a specific pending issue. The regulation gives its own example: for consideration at an open session of an FDA advisory committee.
That single sentence is the legal basis for the briefing materials that appear before an advisory committee meeting. It explains why those documents exist at that moment and not before, and why they are a summary of selected portions rather than the file.
State three: the approval letter has been sent, and the list described above becomes available.
What the summary is, and what it is not
The regulation is unusually careful about the status of the published summaries, and the caution is worth carrying.
The summaries do not constitute the full reports of investigations on which the safety or effectiveness of the drug may be approved. They are a summary of the evidence FDA evaluated, not the evidence itself.
For an application approved on or after 1 July 1975, the summary takes the form of a Summary Basis of Approval. It may be prepared in one of two ways: the applicant may draft one, which the Center for Drug Evaluation and Research reviews and may revise, or the Center may prepare it itself.
For applications approved before that date, the equivalent is internal agency records describing the safety and effectiveness data — with two deletions specified. Names or information identifying patients, test subjects or investigators. And any inappropriate gratuitous comments unnecessary to an objective analysis.
That second deletion is a small, revealing detail about what internal review memoranda actually contain before anyone edits them.
The three things that stay private
Three categories are not available for public disclosure unless they were previously disclosed, or unless they relate to an abandoned product and do not represent a trade secret or confidential commercial information.
Manufacturing methods or processes, including quality control procedures.
Production, sales, distribution and similar data — except that an aggregated compilation prepared so that it does not reveal the underlying protected information may be disclosed.
Quantitative or semiquantitative formulas.
Read that first one against the questions people most want answered. How a product is actually made, and how its quality is controlled during manufacture, is the category the disclosure rule specifically withholds.
That is worth knowing before assuming that a public file answers a manufacturing question. It also frames what an inspection record can and cannot substitute for.
When an unapproved application's data becomes public
There is a separate list governing safety and effectiveness data that was never disclosed. It becomes available on request, unless extraordinary circumstances are shown, when any one of six events occurs.
No work is being or will be undertaken to have the application approved. A final determination is made that the application is not approvable and all legal appeals have been exhausted. Approval is withdrawn and all legal appeals have been exhausted. A final determination is made that the drug is not a new drug.
Two more are timing rules tied to generics. For an application under the branded pathway: the effective date of approval of the first abbreviated application referring to that drug. Or the date such an approval could have been made effective, had one been submitted. And for an abbreviated application itself, when FDA sends its approval letter.
The practical reading is that unsuccessful applications go public on a much slower and more conditional clock than successful ones.
What a complete response letter is
FDA sends a complete response letter when it determines it will not approve an application in its present form.
The letter describes all of the specific deficiencies the agency has identified, and reflects FDA's complete review of the data submitted, identifying any amendments the agency has not yet reviewed.
There is one shortcut written into the rule. If FDA determines after filing that the data submitted are inadequate to support approval, it may issue the letter without first conducting required inspections or reviewing proposed labeling.
And where possible, the letter will recommend actions the applicant might take to place the application in condition for approval.
That framing matters. A complete response letter is a list of deficiencies with, often, a route out of them attached. Reading it as a verdict on a molecule overstates it.
What has to happen next, and the clocks that start
After receiving one, the applicant must take one of three actions.
Resubmit, addressing all identified deficiencies. The resubmission itself starts a new review cycle, whose length depends on how FDA classifies it. A class 1 resubmission of an application or efficacy supplement starts a new two-month cycle. A class 2 resubmission starts a new six-month cycle. A major resubmission of an abbreviated application starts a new six-month cycle.
Withdraw the application. The rule states that this is without prejudice to a later submission.
Or request an opportunity for a hearing on whether there are grounds for denying approval. Within 60 days of that request, or another agreed period, FDA will either approve the application or refuse to approve it and give written notice of an opportunity for a hearing.
Doing nothing has a defined consequence. FDA may treat a failure to act within one year of the letter as a request to withdraw the application, unless an extension has been requested. The rule says FDA will grant any reasonable request for one. If the agency treats inaction that way, it notifies the applicant in writing, and the applicant has 30 days to explain why the application should not be withdrawn and to request more time. No response within 30 days, and the application is deemed withdrawn.
Whether you get to read the letter
This is where the two regulations meet, and the answer depends on what happened afterward.
A complete response letter is correspondence between FDA and the applicant relating to the application. The post-approval disclosure list makes all such correspondence, and written summaries of oral discussions, available once an approval letter has been sent for that application.
So where an application was eventually approved, the earlier correspondence sits inside the category that becomes public at approval.
Where no approval letter is ever sent, the post-approval list does not operate at all, and the separate six-event list above governs when unreleased material becomes available — a slower and more conditional path.
The practical consequence is worth stating plainly. Public knowledge that a company received a complete response letter often originates with the company's own announcement rather than with an agency publication. The disclosure machinery for an unapproved application has not yet been triggered.
Where to look
FDA maintains a public database of approved drugs. Its page is titled Drugs@FDA: FDA-Approved Drugs, and it offers a search by drug name, active ingredient, or application number.
The application number is the most precise of the three, because a brand name can change and an active ingredient can appear across many products and dosage forms.
The regulation also names a separate publication: a list of approved applications and abbreviated applications entitled "Approved Drug Products with Therapeutic Equivalence Evaluations", which it describes as updated monthly.
One habit makes the difference between reading the file and reading a summary of a summary. Look for the agency's own review documents rather than the label alone. The label is the conclusion; the review is the reasoning, and the disclosure rule exists to make the reasoning available.
Sources
- 21 CFR 314.430 — Availability for public disclosure of data and information in an application or abbreviated applicationParagraph (a) for the scope of what counts as the application, including investigational new drug applications, drug master files, supplements and postmarketing reports, and the definition of safety and effectiveness data as all studies and tests on animals and humans and all studies of identity, stability, purity, potency and bioavailability. Paragraph (b) for non-disclosure of an application's existence before an approval or tentative approval letter. Paragraph (c) for no disclosure where existence has not been acknowledged. Paragraph (d)(1) for no pre-approval data disclosure and the Commissioner's discretion to disclose a summary of selected portions for a specific pending issue, with the open advisory committee session given as the regulation's own example. Paragraph (e) for the post-approval list available immediately absent extraordinary circumstances, including the monthly "Approved Drug Products with Therapeutic Equivalence Evaluations" list; (e)(2) for the summaries, the statement that they do not constitute the full reports of investigations, the pre-1975 internal-records form with its two required deletions, and the Summary Basis of Approval for applications approved on or after July 1, 1975 together with the two ways it may be prepared; (e)(3) for protocols; (e)(4) for adverse reaction and product experience reports with identifier deletions; (e)(5) for the ingredient list; (e)(6) for assay and analytical procedures; and (e)(7) for all correspondence and written summaries of oral discussions between FDA and the applicant. Paragraph (f) for the six events triggering availability of previously undisclosed safety and effectiveness data. Paragraph (g) for the three categories not available for public disclosure — manufacturing methods and processes including quality control procedures, production and sales and distribution data with the aggregation exception, and quantitative or semiquantitative formulas. ⛔ A first request for this section returned HTTP 503 at 4,415 bytes; it was re-requested after a 25-second pause and returned 200 at 17,215 bytes, which is the capture read here.
- 21 CFR 314.110 — Complete response letter to the applicantParagraph (a) for when FDA sends a complete response letter; (a)(1) for the description of all specific deficiencies; (a)(2) for the complete review of submitted data and identification of unreviewed amendments; (a)(3) for issuance without inspections or labeling review where data are inadequate; and (a)(4) for recommending actions to place the application in condition for approval. Paragraph (b) for the three applicant actions — resubmission addressing all deficiencies, withdrawal without prejudice to a later submission, and a request for an opportunity for a hearing — together with the class 1 two-month and class 2 six-month new review cycles, the major-resubmission six-month cycle for abbreviated applications, and the 60-day response period on a hearing request. Paragraph (c) for the one-year inaction rule, the written notification, the 30-day window to respond and request an extension, FDA's commitment to grant any reasonable extension request, and the deemed withdrawal.
- Drugs@FDA: FDA-Approved DrugsOnly what was read on the page: its title, "Drugs@FDA: FDA-Approved Drugs", and its search prompt, "Search by Drug Name, Active Ingredient, or Application Number". No search was run and no claim about search results is drawn from it. A same-host control in the same run, a nonsense path under /scripts/cder/, returned HTTP 404 at 17,737 bytes against this page's 200 at 8,541 bytes, confirming the host does not answer 200 for every path.
Frequently asked questions
What becomes public the day a drug is approved?
A defined list, immediately available unless the applicant shows extraordinary circumstances. A Summary Basis of Approval summarizing the safety and effectiveness data FDA evaluated. Protocols for tests or studies, unless shown to be trade secret or confidential commercial information. Adverse reaction reports, product experience reports and consumer complaints, with names and identifying information for patients and third parties deleted. A list of all active ingredients and previously disclosed inactive ingredients. Analytical procedures, subject to the same trade-secret exception. And all correspondence and written summaries of oral discussions between FDA and the applicant relating to the application.
Is the published summary the same as the trial data?
No, and the regulation says so directly. The summaries do not constitute the full reports of investigations on which the safety or effectiveness of the drug may be approved. A Summary Basis of Approval is a summary of the safety and effectiveness data and information evaluated by FDA during the approval process. It may be drafted by the applicant subject to FDA review and revision, or prepared by the Center for Drug Evaluation and Research.
Can I find out how a drug is manufactured?
Not through this route. Manufacturing methods or processes, including quality control procedures, are among three categories not available for public disclosure. Two conditions can lift that: previous disclosure, or a relationship to an abandoned product where the material is not trade secret or confidential commercial or financial information. The other two are production, sales and distribution data — subject to an exception for aggregated compilations that do not reveal protected information — and quantitative or semiquantitative formulas.
Why do advisory committee briefing documents exist before approval?
Because of a narrow discretionary carve-out. Where an application's existence has been disclosed but no approval letter has been sent, no data in it is available. The exception is narrow: the Commissioner may disclose a summary of selected portions of the safety and effectiveness data appropriate for public consideration of a specific pending issue. The regulation's own example of such an issue is consideration at an open session of an FDA advisory committee.
What is a complete response letter?
It is what FDA sends when it determines it will not approve an application in its present form. The letter describes all of the specific deficiencies the agency has identified and reflects its complete review of the submitted data, identifying any amendments not yet reviewed. Where the data are inadequate to support approval, FDA may issue it without first conducting required inspections or reviewing proposed labeling. Where possible, it recommends actions that might place the application in condition for approval.
What happens after a company receives one?
It must resubmit, addressing all deficiencies. Or withdraw the application, which the rule states is without prejudice to a later submission. Or request an opportunity for a hearing on whether there are grounds for denying approval. A resubmission starts a new review cycle whose length depends on classification: two months for a class 1 resubmission, six months for a class 2. Failure to act within one year may be treated as a request to withdraw, after written notice and a further 30 days to respond.
Are complete response letters published?
It depends on what happened next. Such a letter is correspondence between FDA and the applicant about the application, and the post-approval disclosure list makes all such correspondence available once an approval letter has been sent for that application. Where no approval letter is ever sent, that list does not operate. A separate six-event list then governs when previously undisclosed material becomes available. Two of those events are that no work is being undertaken toward approval, and that a final determination the application is not approvable has been made with all legal appeals exhausted.