The Food and Drug Administration on Sunday announced new manufacturing exemptions for cell and gene therapies, easing certain regulatory requirements to speed development while maintaining safety standards for complex, often personalized treatments.
The FDA said the changes apply to chemistry, manufacturing, and control requirements for FDA cell and gene therapy, known as CGTs, which are frequently produced in small batches or tailored to individual patients. The policy was detailed in two agency news releases issued on Sunday.
FDA Commissioner Marty Makary described the move as “common-sense reforms” designed to reflect how these therapies are developed and manufactured. He said the agency aims to remove barriers that can slow progress without improving patient safety.
The concessions were outlined by the FDA’s Center for Biologics Evaluation and Research, which oversees biologics, including cell and gene therapies. The center said it will adjust certain requirements to accommodate the “unique characteristics of these innovative therapies.”
FDA Cites Flexibility for Small-Batch, Patient-Specific Therapies
Under the new approach, the FDA will not require some investigational gene therapies to meet specific manufacturing standards as they advance beyond Phase I trials. Those standards are outlined in Chapter 600 of the Code of Federal Regulations and typically apply to all biologics entering Phase II or Phase III testing.
The agency said the exemptions recognize that traditional manufacturing rules may not fit therapies that are customized for a single patient or produced in limited quantities. Developers have long argued that applying uniform standards can be impractical for such products.
Makary said the updated framework is intended to reduce unnecessary regulatory friction. “These reforms reflect the reality of how FDA cell and gene therapy are made and tested,” he said in a statement.
The FDA emphasized that the exemptions are limited in scope and apply only to certain manufacturing specifications, not to broader requirements for demonstrating safety or effectiveness.
Exemptions Target Later-Stage Trials and Minor Process Changes
The agency also said it will take a more lenient stance on what it called “minor manufacturing changes” as FDA cell and gene therapy moves into later stages of development. Companies will be allowed to adjust production processes if they can show the changes do not meaningfully alter the product.
Such flexibility is intended to help developers refine manufacturing methods without triggering delays or additional regulatory hurdles. The FDA said sponsors must still provide data demonstrating that any changes do not affect quality or performance.
In addition, the FDA said it is open to modifications of a therapy’s commercial specifications, signaling a willingness to discuss adjustments as products move closer to approval and wider use.
According to the agency, these measures are designed to support innovation while recognizing the technical challenges of scaling up complex biologic products.
Agency Says Safety Standards Remain Intact
Despite the new flexibilities, it stressed that its oversight of the FDA cell and gene therapy will remain strict. The agency said it will continue to apply “rigorous quality standards through appropriate control measures.”
“These changes will enable progress while not compromising or undermining the FDA’s ability to assure safety, purity, and potency of a product,” the agency said in a statement.
The manufacturing exemptions build on a series of recent FDA initiatives aimed at supporting CGT development. In November, the agency introduced a “plausible mechanism” pathway to help therapies for rare diseases reach patients more quickly.
That pathway allows regulators to consider the biological basis of a disease and how a therapy is expected to work, which can be especially important for conditions affecting small patient populations.
In October 2025, the FDA also released draft guidance documents proposing to streamline CGT reviews. Among the proposals was expanded use of self-controlled trials, which compare patients to their own baseline data rather than to separate control groups.
The FDA said the latest manufacturing changes are part of its broader effort to modernize regulation as advanced therapies become more common.
