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# Support For and Ideas to Change GDUFA 4
- URL: https://www.fdaweb.com/support-for-and-ideas-to-change-gdufa-4/
- Published: 2026-10-22T18:38:44.000Z
- Updated: 2026-10-22T18:38:44.000Z
- Author: David McFarland
- Tags: Drugs

The Association for Accessible Medicines (AAM), which represents America’s generic and biosimilar drug sector, says it “strongly supports” the proposed GDUFA 4 commitment letter outlining the agreement negotiated between FDA and the industry. “GDUFA has played an essential role in strengthening the generic drug review process, helping to ensure that patients have timely access to safe, effective, and affordable medicines,” the association’s [comment letter](https://www.regulations.gov/comment/FDA-2025-N-0873-0027?ref=fdaweb.com) says.

“During the GDUFA IV negotiations, the industry participants focused on how to enhance communications, further streamline the ANDA assessment process, improve the outlook for complex generics, and enhance the inspection and post-inspection processes,” the letter says. “Recognizing the significant resource constraints facing FDA and the continued economic pressures on the generic medicines sector, FDA and industry aimed to achieve modest but meaningful cost-neutral improvements to the program. Maintaining a sustainable user fee structure is essential because disproportionate fee growth can discourage submissions, reduce market participation, and ultimately undermine competition and patient access.”

AAM listed these items from the commitment letter that address many of its objectives:

- commitments intended to reduce the number of assessment cycles;
- meetings and controlled correspondence;
- drug master files;
- inspections;
- transparency; and
- encouraging domestic manufacturing.

If the GDUFA 4 commitment letter is adopted, the comment concludes, “the true measure of success will be consistent implementation of its provisions, earlier and more actionable communication, fewer avoidable review cycles, greater transparency, and more timely access to affordable medicines.”

In its response, MedShadow Foundation says its two-year investigation into the quality of marketed generic drugs found that an approved generic drug can perform differently than its reference-listed drug. The[ letter](https://www.regulations.gov/comment/FDA-2025-N-0873-0026?ref=fdaweb.com) also says there can be differences between two generics based on the same innovator product.

“The proposed GDUFA 4 agreement contains extraordinarily detailed performance goals for FDA — deadlines for review, inspections, meetings, and response times to manufacturers,” it says. “Where are the comparable performance goals for assuring the continuing quality of generic drugs after approval”?

MedShadow says GDUFA 4 should establish and fund a risk-based program of independent postmarket testing of generic drugs obtained from the actual U.S. commercial supply chain. It says drug companies have a responsibility to ensure that their product remains equivalent to the reference-listed drug when it reaches the end user. “The cost of proving continued safety and efficacy belongs with the pharmaceutical company,” it says.

The letter says FDA should take the lead in developing a system connecting every dispensed generic to current agency quality information. It says a QR code could tell patients and pharmacists about drug changes, who manufactured the finished drug and where, whether the product or lot has been recalled, and whether FDA has changed its therapeutic-equivalence

determination. “FDA already has this information,” it says. “Connect it to the product in the patient’s hand.”

It also calls for:

- increasing resources for stronger oversight of postmarketing safety;
- adding the ability to find, read, and respond to safety signals sooner; and
- making important product information easily available to the people taking the drugs.