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# Prevention Is the Best Counter to CRL Risk: Blog Post
- URL: https://www.fdaweb.com/prevention-is-the-best-counter-to-crl-risk-blog-post/
- Published: 2026-09-03T12:00:00.000Z
- Updated: 2026-09-14T12:05:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161729

The consulting firm RMS says its analysis of over 300 complete response letters (CRLs) posted by FDA since 2025 shows that the most effective strategy for coping with CRL risk is prevention. Writing in the *Real Economy* [blog](https://realeconomy.rsmus.com/insights-from-fda-complete-response-letters-preventing-costly-drug-approval-delays/?ref=fdaweb.com), RMS says, “Companies that identify and resolve potential regulatory, quality, and manufacturing issues early will be better positioned to avoid lengthy approval delays, preserve capital, and bring therapies to patients more quickly.”

The firm says its CRL analysis found that rejection reasons differed notably between products that were eventually approved and those still unapproved. Among the 219 products that ultimately won FDA approval, product quality/CMC (chemistry, manufacturing, controls) issues were the most common deficiency, accounting for 90 rejections. “While these issues can be costly and difficult to resolve,” it says, “their prevalence among later-approved products suggests they are often remediable rather than a hard barrier to approval.”

According to the blog, CRL-to-approval times show the importance of addressing issues early. On average, it says, the time between CRL and final approval is 2.4 years, with a median of 1.5 years. “That delay carries a real cost,” it says. “Companies must fund remediation while also absorbing lost revenue. And for companies that were primarily rejected because of product quality/CMC, the median stretches to over 21 months, a stretch that can strain cash flow.” RMS recommends that companies:

- strengthen CMC readiness before submission;
- stress-test regulatory submissions;
- invest in early quality systems and compliance capabilities;
- plan for regulatory contingencies; and
- learn from historical CRLs.