# 2026-16452: FDA's Guide to Speedy Drug Approval Dates

2026-16452, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-13, effective 2026-08-13; PRIA reads it as touching household money (as of 2026-08-20).

- Canonical: https://policyrisk.com/federal-register/2026-16452
- As of: 2026-08-20
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16452
- Title: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 52305
- Published: 2026-08-13
- Effective: 2026-08-13
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-20

## In one line

FDA's Guide to Speedy Drug Approval Dates

## Summary

The FDA just released final guidance on how drug companies can have formal meetings with them about new prescription drugs. This helps drug makers and the FDA work better together to speed up drug reviews, especially for products under the Prescription Drug User Fee Act. The new rules kick in right away and aim to make meetings clearer and more helpful without extra costs.

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This guidance outlines the recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of new drug or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance of the same title issued on September 22, 2023.

## Effects PRIA read

- Final FDA PDUFA Meeting Guidance: benefit, medium. If you are a sponsor or applicant for a prescription drug or biologic under PDUFA, the FDA published final guidance on August 13, 2026 that outlines recommended procedures for formal meetings with FDA. The guidance describes meeting types, formats, timelines, and standardized steps for requesting,…
- Added Scenarios, Clarifications, Formats: benefit, low. The final guidance adds additional scenarios for Type D meetings, clarifies Initial Targeted Engagement for Regulatory Advice for CDER and CBER product meetings, and includes information on meeting formats the FDA may grant. These changes finalize edits to the draft guidance originally issued on Se…

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## Sources
- [2026-16452 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/13/2026-16452/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-applicants-of-prescription)
- [2026-16452 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-13/pdf/2026-16452.pdf)

## Related
- [Previous: 2026-16451, Submission for OMB Review; Comment Request](https://policyrisk.com/federal-register/2026-16451)
- [Next: 2026-16453, Southern California Edison Company; Notice of Intent To Prepare an Environmenta…](https://policyrisk.com/federal-register/2026-16453)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-16452 (as of 2026-08-20).