
FDA Enables Instant Access to CRLs—Insights for Drug Discovery and Manufacturing
The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.
After saying in July 2025 that it would embrace “radical transparency” by
“This is a milestone day for the agency,” FDA Commissioner Marty Makary, MD, MPH, said in an agency press release (2). “By embracing radical transparency—one of the guiding principles of this administration—we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”
Are companies responding, and how?
One newly published CRL that attracted immediate attention was addressed to
“Let’s be clear: the CRL reveals a devastating truth—FDA moved the goalposts,”
Following FDA’s initial disclosure of transparency regarding CRLs, Pharmaceutical Technology® covered the responses of
“I wonder if part of the problem is that many biotechs do not have sufficient experience in-house, and rely on contract organizations,” Pharmaceutical Technology® Editorial Advisory Board member
What does this mean for drug discovery, development, and manufacturing?
This policy shift ostensibly gives developers, including those in discovery, preclinical, and clinical domains, much earlier access to FDA feedback on safety and effectiveness issues detailed in CRLs (2). Access to these real-time communications enables sponsors to detect recurring deficiencies and better align their study design and regulatory strategies with the agency’s expectations.
Also, CRLs often cite detailed chemistry, manufacturing, and controls (CMC) deficiencies. With immediate public access to these letters—albeit redacted for trade secrets and proprietary information—developers gain indirect insight into the most common CMC pitfalls flagged by FDA. This heightened awareness may allow for more proactive quality assurance and process control planning.
On the other hand, although FDA has committed to “prompt” publication and redaction of confidential information such as trade secrets and personal identifiers, precise timing as it relates to CRL issuance remains unspecified (2). Additionally, the policy currently covers human drug and biologic applications; direction on other application types has not been clarified.
FDA’s searchable database of CRLs can be accessed
References
1. FDA.
2. FDA.
3. MAPS.
4. Cole, C.
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