FDA to reduce review timelines for new drugs from 12 months to 1-2 months.

There is recent news that the FDA has unveiled a plan to shorten review times for new drugs to one or two months.

This means pharmaceutical companies may be able to monetise their inventions early. The doctors may be able to obtain new medications for patients with life-threatening diseases and severe conditions more quickly than they currently do.

Announcement CNPV

The USFDA announced its Commissioner’s National Priority Voucher (CNPV) program to benefit Americans’ health. Drug developers can use the new voucher to join a special FDA priority program that shortens review time from about 10-12 months to 1-2 months after a sponsor’s final drug application submission.

However, physicians will need to consider the safety of these rapidly approved drugs and their potential costs to patients. Under the new program, the FDA aims to approve certain medications within one to two months through the agency’s accelerated approval program. Draft Guideline

The USFDA issued a draft guidance for industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." This guidance pertains to drugs granted accelerated approval, for which sponsors must conduct post-approval confirmatory studies to verify and describe the expected effects on irreversible morbidity, mortality, or other clinical benefits. The draft guidance explains FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including the factors FDA considers when determining if a confirmatory trial is underway before accelerated approval. Key Dates Comments on the draft guidance, whether electronic or written, should have been submitted by March 10, 2025, to ensure the Agency considers them before finalising the guidance. Supplementary Information The draft guidance pertains to the requirements for confirmatory studies for drugs granted accelerated approval. The Consolidated Appropriations Act of 2023 (CAA) amended section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enhance the timely completion of trials. The FDA may require studies to be underway before approval or within a specified timeframe after approval. The guidance clarifies the interpretation of "underway" and the FDA's policies. The guidance is consistent with the FDA's Good Guidance Practices regulation (21 CFR 10.115). It represents the FDA's current thinking and does not establish new rights or binding requirements. Alternative approaches can be used if they satisfy the applicable statutes and regulations. Paperwork Reduction Act of 1995 The document addresses the Paperwork Reduction Act of 1995 (PRA), which requires Federal agencies to obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The FDA had invited comments on: 1. Whether the proposed collection of information is necessary 2. The accuracy of the FDA's burden estimate 3. Ways to enhance the quality, utility, and clarity of the information 4. Ways to minimise the burden of the collection of information The draft guidance outlines the FDA's policies for implementing statutory authority related to accelerated approvals, and the FDA will use reports to monitor the progress of confirmatory trials. The document also references previously approved FDA collections of information related to human subject protection, investigational new drug applications, new drug applications, postmarketing reports, and biologics license applications. Based on my understanding and the news published in RAPS, the pharmaceutical industry has some questions about the draft guideline. Industry groups also requested greater clarity about when the agency will provide feedback on confirmatory trials and how the guidance will align with the agency’s other policies on accelerated approval. Additionally, the Pharmaceutical Research and Manufacturers of America (PhRMA) questioned the necessity of confirmatory studies for certain treatments granted accelerated approval, particularly for programs that address unmet medical needs. The group argued that Congress did not intend to require confirmatory trials for all drugs receiving accelerated approval.

Commissioner’s National Priority Voucher (CNPV)

In the meantime, as briefly mentioned at the beginning of the post on June 17, 2025, FDA Commissioner Marty Makary announced a new initiative aimed at enhancing the health interests of the United States population, namely, the Commissioner’s National Priority Voucher (CNPV).

Obviously, many questions from the industry remain, and the FDA tried to address them on June 17, 2025, post.

What’s the difference between the Commissioner’s National Priority Voucher (CNPV) and the existing Priority Review and Priority Review Voucher (PRV) programs? The FDA responds that these programs are separate and not mutually exclusive. The current priority review programs and PRV programs will continue as they are. The CNPV program will commence in 2025 and incorporates elements from the priority review and PRV programs, featuring distinct timelines for review, product designation, undesignation, and a ban on the sale of vouchers.

These vouchers are non-transferable and valid for two years. They can be used at any stage of development.