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# GDUFA 2 Aims to Improve First-cycle ANDA Reviews: Woodcock
- URL: https://www.fdaweb.com/gdufa-2-aims-to-improve-first-cycle-anda-reviews-woodcock/
- Published: 2017-03-02T12:00:00.000Z
- Updated: 2026-09-14T22:09:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138111

The second iteration of the Generic Drug User Fee Act (GDUFA), which begins 10/1 once approved by Congress and signed into law, would aim to improve first-cycle review approvals, CDER director **Janet Woodcock** told a House Energy and Commerce health subcommittee hearing 3/2\. Currently, first-cycle generic approvals are running about 10% approved, which is considerably less than the 80% first-cycle innovator products enjoy, according to Woodcock. “Historically, it has taken on average about four review cycles to approve an ANDA as a result of deficiencies by generic drug sponsors in submitting complete applications,” she said.

A low first-cycle review rate results in the “submission of numerous amendments to applications by the companies to correct deficiencies in the original ANDAs and comprises a huge amount of re-work for FDA and industry alike,” Woodcock said in her testimony. “Currently, about 1,800 applications are back with industry awaiting resubmission to correct deficiencies in the original application. More work by both FDA and industry will be necessary to have the filings be ‘right the first time.’ Improvement may take some time. In the first few years of the Prescription Drug User Fee Act (PDUFA) program, the first cycle approval rate for new drugs was as low as 23%. Now it is about 80% on average. Achieving this was the result of many years of cooperative work by the Agency and industry in establishing standards and meeting these expectations.”

Under GDUFA2, additional resources would permit pre-ANDA program enhancements, according to Woodcock. “To reduce the number of cycles to approval, particularly for complex products, GDUFA 2 would establish a pre-ANDA program,” she said. “It would clarify regulatory expectations for prospective applicants early in product development and help applicants develop more complete submissions, thus promoting a more efficient and effective review process. The GDUFA 2 pre-ANDA program would establish three types of meetings for complex products. In a product development meeting, FDA would provide targeted advice concerning an ongoing ANDA development program. Pre-submission meetings would give applicants an opportunity to discuss and explain the content and format of an ANDA before it is submitted. Mid-review-cycle meetings would occur post-submission, after the last key review discipline has communicated deficiencies, and would enable applicants to discuss current concerns and next steps.”

Woodcock said the agency intends to issue a guidance concerning the pre-ANDA program to outline policies and procedures. “In addition, the Agency intends to establish metric goals for product development and pre-submission meetings,” she said. “For products that are not complex, GDUFA 2 would direct the agency to establish metric goals for FDA to issue product-specific guidance.”

Asked by subcommittee chair **Michael Burgess** (R-TX) how improved first-cycle reviews will become during the next five years, Woodcock responded: “If we can get to 20% to 25% then that would be a success.” She noted that beginning 10/1, the user fee program would allow for a “first generic” submission to be reviewed and approved in eight months if the submission was complete and in good quality. It would be difficult to shorten reviews more because of many manufactures are located overseas and there needs to be inspections. Woodcock said there have been numerous cases where some foreign companies have manipulated samples and other data integrity issues have raised alarm.

Ranking member **Gene Green** (D-TX) raised concerns about FDA’s large employee vacancies and a hiring freeze ordered across government under the Trump administration that will affect the agency’s productivity. An optimistic Woodcock noted that FDA’s hiring problems have been persistent for last five to six years. “We are working with the new administration and we hope that we will be able to address these issues,” she said.

  
Rep. **Frank Pallone** (D-NJ) asked what FDA is doing about certain brand companies blocking generic companies from obtaining testing sample due to a risk evaluation and mitigation strategy (REMS) being in place. “We are willing to review the testing protocol and send letters to brand companies to make clear that drugs under a REMS can be used for bioequivalence testing, but we cannot compel companies to make samples available, and we have addressed the issue with the \[Federal Trade Commission\].” Asked whether Congress should take legislative action, Woodcock politely responded: “We don’t know the answer to that and it’s a problem we and the companies struggle with and it has delayed availability of generics.”