Yes it seems confusing a little bit. Here is a summary of the process for payment & approval of the PDUFA ( as published in the Federal Register as well as the fees involved), then submission of TDAPA: A- NEW PDUFA DATE EXPECTED IN 1H 2026 WITHIN 30 DAYS OF NDA RESUBMISSION. December 29, 2025 7:05am EST B- UPDATE - UNICYCIVE THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF OXYLANTHANUM CARBONATE (OLC) NEW DRUG APPLICATION (NDA) RESUBMISSION. January 29, 2026 9:15am EST. FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026.
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for prescription drug user fees for fiscal year (FY) 2026 Prescription Drug User Fee Rates for Fiscal Year 2026 (PDUFA) 1. PDUFA Application Fees The most direct financial requirement is the payment of user fees at the time of submission. These fees are updated annually. • Application Fee (FY 2026): For a New Drug Application (NDA) or Biologics License Application (BLA) requiring clinical data, the fee is $4,682,003. • Waivers and Reductions: o Small Businesses: Companies submitting their first human drug application may be eligible for a waiver if they meet specific revenue and employee criteria. o Orphan Drugs: Applications for drugs with "Orphan" status are typically exempt from these fees if the company’s gross worldwide revenue was less than $50 million in the previous year. • Payment Failure: An application is not considered "accepted for filing" until the fee is paid in full; failure to pay results in immediate rejection of the submission. 2. Financial Disclosure Rules To prevent bias in clinical data, the FDA's Financial Disclosure Rule (21 CFR 54) requires companies to disclose certain financial interests: • Clinical Investigator Certification: Companies must certify that clinical investigators have no significant financial interests in the company or disclose any such interests (e.g., stock ownership, grants, or royalty payments). • Consequences of Non-Disclosure: If the FDA finds significant financial conflicts that could bias study results, they may refuse to use that data to support the drug's safety or efficacy. 3. Post-Approval & Commercialization Costs Once a drug is approved and commercialized, companies face ongoing financial obligations: • Annual Program Fees: Companies must pay an annual "Prescription Drug Program Fee" for each approved drug product. For FY 2026, this is $442,213 per product (capped at five products per application). • State Licensing & Insurance: Commercialization requires a drug manufacturer license, which often necessitates proof of insurance, a certificate of good standing, and payment of state-specific registration fees. • Marketing Restrictions: While not a direct "fee," the Prescription Drug Marketing Act (PDMA) imposes strict financial and operational rules on the sale of drug samples and distribution to prevent diversion and fraud. 4. No "Pay-to-Play" for Approval Crucially, paying the PDUFA fee does not guarantee approval. The FDA maintains that there is no direct connection between the fee paid and the final scientific review outcome. The fees are solely intended to fund the personnel and resources needed for the review process. These FDA documents detail the specific PDUFA application and annual program fees for fiscal years 2025 and 2026: I. Background Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h) establish two different kinds of user fees. Fees are assessed as follows: (1) application fees are assessed on certain types of applications for the review of human drug and biological products and (2) prescription drug program fees are assessed on certain approved products (section 736(a) of the FD&C Act). The statute also includes conditions under which such fees may be waived or reduced (section 736(d) of the FD&C Act), or under which fee exceptions, refunds, or exemptions apply (sections 736(a)(1)(C) through (H), 736(a)(2)(B) through (C), and 736(k) of the FD&C Act). II. Fee Revenue Amount for FY 2026 The base revenue amount for FY 2026 is $1,434,377,467 (see section 736(b)(1)(A) and (b)(3) of the FD&C Act). This amount is prior to any adjustments made for inflation, the strategic hiring and retention adjustment, CPA, additional dollar amount, operating reserve adjustment (if applicable), and additional direct costs (see section 736(b)(1) of the FD&C Act).
5. Submission of TDAPA Application once PDUFA has been paid for & approved by June 29, 2026.
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