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This on-demand webinar is FREE. This webinar was recorded on June 10, 2019.

About

Learn about FDA economic assistance and economic incentives so you may maximize potential benefits. Economic assistance is available in the pre-approval period of drug development for the conduct of clinical trials.  Economic incentives are granted post-approval to reward innovation in drug development.

Hear directly from the FDA subject matter experts as we detail the various types of waivers covered in the draft Guidance for Industry Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF - 632KB).

For PDUFA, the webinar will provide background information on the different types of fees.   Attendees will gain knowledge and understanding of the regulatory criteria and process for waivers, exemptions, and refunds.

The Biosimilar User Fee Amendments of 2017 (BsUFA II) was signed into law on August 12, 2017.  The goal of this webinar is to provide an overview of the biosimilar user fee program, describe waivers and refunds, and common pitfalls.

The Office of Orphan Product Development (OOPD) will provide an overview of several of their programs that provide incentives for the development of products for the diagnosis and/or treatment of rare diseases or conditions

The Office of Generic Drug Products (OGD) will address the various types of exclusivity currently available to all applicants. The webinar will also cover the logistics of priority review vouchers (PRV). Specifically, they will provide general information on three FDA priority review voucher programs and specific information on how to redeem a voucher, what information to submit, and when to pay. This information is intended to help the audience understand the differences among the PRV programs and ensure applicants appropriately navigate the procedural landscape for voucher redemption.

Topics Covered

• PDUFA waivers, reductions, and refunds
• BsUFA fee structure and small business waivers
• Orphan Drug program tax credits, waivers, exclusivity, grants program, and rare pediatric disease designation
• Exclusivity types, exclusivity scenarios and timing, exclusivity board, generics timeline
• Priority review vouchers to include tropical diseases, rare pediatric diseases, material threat medical countermeasure
• Understand situations where firms can request a waiver or refund
• Highlight common mistakes that could impact firms
• Understand the basic eligibility requirements to receive a PRV
• Hear directly from the FDA subject matter experts on policies and procedures for PRV redemption

Intended Audience

• Consultants and regulatory affairs professionals involved with user fees
• Regulatory affairs professionals and researchers working on developing products to treat rare diseases or conditions
• Regulatory affairs professionals working on NDA and BLA user fees
• Small pharmaceutical companies
• Drug developers
• Regulatory affairs professionals working on INDs, NDAs, BLAs applications
• Financial officers working in drug development field

FDA Resources

• Economic Assistance and Incentives for Drug Development
• Developing Products for Rare Diseases & Conditions
• BsUFA website (http://www.fda.gov/bsufa) 
• FDA Guidance: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry
• Guidance for Assessing User Fees Under the Biosimilar User Fee Assessments of 2017 
• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (May 2018)
• 21 USC § 360n Priority review to encourage treatments for tropical diseases
• 21 USC § 360ff Priority review to encourage treatments for rare pediatric diseases
• 21 USC § 360bbb-4a Priority review to encourage treatments for agents that present national security threats
• Tropical Disease Priority Review Vouchers, Guidance for Industry
• Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
• Material Threat Medical Countermeasure Priority Review Vouchers, Draft Guidance for Industry