How many Complete Response Letters has the FDA published?

459 published records as of 13 August 2026, of which 444 were typed COMPLETE RESPONSE at the last full analysis. The FDA released more than 200 on 10 July 2025, a further 89 on 4 September 2025, and has added letters on a rolling basis since.

Is the FDA still releasing Complete Response Letters?

Yes, for now, after a three-month interruption. Releases stopped in April 2026 following a citizen petition filed through Covington & Burling, which argued the FDA must involve sponsors in disclosure decisions. The agency resumed on 10 July 2026 with a batch of 14 letters dating back to 23 April, and the archive has kept growing since. HHS has said only that it is evaluating the process and potential next steps, so the policy is not settled.

How long does a Complete Response Letter delay approval?

Median time from CRL receipt to approval was 1.28 years in Dilek et al.'s 43-therapeutic cohort. McCarthy & O'Boyle measured roughly 709 days, about 23 months, of added time against first-cycle approval. RSM US LLP found an average above 2.5 years across the first 200-plus released letters.

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FDA Complete Response Letter statistics: the complete record

One page, every verified number on the FDA's published rejection letters, with the receipt for each. Re-verified against the live openFDA API, and built to remain the record if the releases stop.

By Alex Cooke, Founder & CEO, Phase 3 Search · Archive: 459 records as of 13 August 2026 · Last verified 20 August 2026

How many CRLs has the FDA published?

459 published records as of 13 August 2026, of which 444 were typed Complete Response Letter at the last full analysis. Four records pre-date the 2008 rule that created the instrument and were issued as Not Approvable letters. The rest are other actions the FDA files in the same dataset.

Date	Release	What it contained	Cumulative
10 July 2025	First tranche, 200+	Applications reviewed 2020-2024, all subsequently approved	200+
4 September 2025	Second batch, 89	Applications pending or withdrawn, not ultimately approved; real-time release policy announced	~290
11 May 2026	Rolling additions	Archive reported at nearly 350 letters (BioSpace)	~350
April 2026	Releases stop	A citizen petition filed through Covington & Burling halts publication for three months	paused
10 July 2026	Releases resume, 14 letters	FDA posts a catch-up batch dating back to 23 April; HHS says it is still evaluating the process	~440
22 July 2026	Phase 3 bulk pull	Full-text download; the analysis in this report	457
13 August 2026	Live API check	Osteal Therapeutics (29 July) and ITM Solucin (7 August) added	459

Check the total yourself: api.fda.gov/transparency/crl.json returns the current record count and last-updated date.

Is the FDA still releasing CRLs?

Yes, for now, and it has already stopped once. Publication halted in April 2026 after a citizen petition filed through Covington & Burling argued the FDA had to involve sponsors in disclosure decisions and guarantee redaction of confidential material. The archive sat still for three months. On 10 July 2026 the agency resumed, posting a catch-up batch of fourteen letters dating back to 23 April, and it has kept adding since. HHS has said only that it is evaluating the process and potential next steps.

Two futures, one page. If releases resume, the table above keeps growing and this record is re-verified with each batch. If the pause hardens into policy, the published archive freezes as the complete public record of FDA rejection letters, roughly 459 records spanning 2002 to mid-2026, and this analysis becomes the definitive read of a closed corpus. Either way, what has already been published cannot be unpublished, and it is analysed here in full.

The headline numbers

Question	Answer	Source
The 74% figure circulating in trade coverage	Real, but it describes 202 letters, not the archive: 150 of the 202 in the FDA's first tranche, all from applications ultimately approved, classified by keyword	Pharma Manufacturing, July 2025
Share of published letters citing manufacturing or quality	62.6% carry a manufacturing or quality deficiency section (286 of 457); 62.5-62.7% across both 2026 pulls	Phase 3 Search, full report
Most common primary deficiency category	CMC, 45%	McCarthy & O'Boyle 2026, 30 approved-after-CRL NDAs
Manufacturing-facility deficiencies	65%; CMC 51%	Dilek et al. 2026, 43 novel therapeutics
Median delay, CRL receipt to approval	1.28 years	Dilek et al. 2026
Added delay versus first-cycle approval	~709 days, about 23 months	McCarthy & O'Boyle 2026
Average CRL to final approval	>2.5 years	RSM US LLP, February 2026, first 200+ letters
Share of CRL'd NDAs later approved	64%; 75% CMC-cited, 44.4% safety-cited	McCarthy & O'Boyle 2026
Facility deficiencies caused by incomplete pre-approval inspections	More than half	RSM US LLP, February 2026
Records currently marked unapproved	32.4% of the analysed archive	openFDA record field; not a recovery rate, see caveat

The two peer-reviewed cohorts answer "what was the primary problem." Archive-wide counts, ours included, answer "what do the letters raise." Both are useful. They are not interchangeable, and the difference is where most published confusion about CRLs comes from. Full reconciliation in the analysis behind these figures, and the counting rule on the how the figure was built page.

Working the other side of this

We place the CMC, quality and technical operations leaders whose job is to keep a company out of this archive. If you want a structured read on where your own programme sits against it, that is a twenty-minute conversation, and the diagnostic our technical operations practice runs before every engagement.