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  5. Regulatory Education for Industry (REdI) Webinar: Financial Incentives for CDER Medical Products – June 10, 2019
  1. CDER Small Business & Industry Assistance (SBIA)

Regulatory Education for Industry (REdI) Webinar: Financial Incentives for CDER Medical Products – June 10, 2019

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Webinar Recordings Speakers Presentations

Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My

Jeen Min, RPh
Commander, United States Public Health Service
Branch Chief
Division of User Fee Management & Budget Formulation
OM | CDER | FDA

Slides

Navigating the World of Biosimilar User Fees

Beena Alex, MPH, MBA
Lead Management Analyst
Division of User Fee Management and Budget Formulation
Office of Management (OM) | CDER | FDA

Slides

Questions and Answers

Jeen Min, Beena Alex

 

Exclusivity –Which one is for me?

Rinku Patel
Patent and Policy Reviewer
Division of Legal and Regulatory Support (DLRS) | Office of Generic Drug Policy (OGDP)
Office of Generic Drugs (OGD) | CDER | FDA

Slides

Questions and Answers

 

 

Priority Review Vouchers – Redemption and General Information

Peter Chen
Team Leader
Division of User Fee Management & Budget Formulation
Office of Management (OM) | CDER | FDA

Slides

Orphan Drugs Program

Roberta Szydlo, RPh, MBA, RAC, BCGP
Captain, U.S. Public Health Service; Program Management Officer    
Office of Orphan Products Development | Office of Clinical Policy and Programs | FDA

Slides

Questions and Answers

Peter Chen, Roberta Szydlo

 

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Hear directly from the FDA subject matter experts as we detail the various types of waivers covered in the draft Guidance for Industry Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF - 632KB).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