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  5. Regulatory Education for Industry (REdI) Webinar: Financial Incentives for CDER Medical Products – June 10, 2019
  1. Development & Approval Process (Drugs)

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

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

CDER SBIA Webinar Series

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Hear directly from the FDA subject matter experts as we detail the various types of waivers covered in the draft Guidance for Industry Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry (PDF - 632KB).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

Date
June 10, 2019
10:00 a.m. – 3 p.m. Eastern
Monday
Location

Recordings and Presentations     Agenda

This on-demand webinar is FREE.

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 SPEAKERS

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

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

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

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

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

FDA Resources

Continuing Education

  • This webinar is RAPS eligible for credit towards a participant’s RAC recertification.
  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • ACRP provides continuing medical education for the completion of this educational activity. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Real time attendance is required.

Questions

For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707 
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