Formal FDA Meetings For Sponsors Or Applications Of PDUFA Products

Since the enactment of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 to 2027, the FDA has issued a revised draft guidance in September 2023. This guidance offers comprehensive recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are designed to address issues related to the development and review of drugs and biological products.

The draft guidance, titled "Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products," is a critical resource for Sponsors and applicants. It provides detailed information and enhanced clarity on the Agency’s expectations for these interactions. By outlining the structure, content, and procedures for these meetings, the guidance helps ensure that Sponsors and applicants are well-prepared and informed. This preparation facilitates more productive and efficient discussions, ultimately aiding in the advancement of drug and biologic development processes. The revised guidance underscores the FDA’s commitment to transparent communication and effective collaboration with industry stakeholders, aiming to improve the overall regulatory review process.