Webinars >>FDA Regulations
Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives​

There are about six expedited approval pathways available to FDA regulated products each with its benefits and nuances. Almost all products are eligible for at least one of these and many are eligible for more than 2 of the expedited approval categories. However, most sponsors do not make the most of these pathways mostly because of poor planning or regulatory oversight. There is need to fully understand the potential of each incentive prior to aiming to use one and to get the best results. There are additional strategies to expedite approval of products with or without a formal designation. Less than 25% of companies are able to maximize the benefit of an expedited approval designation due to logistical, practical or personnel issues.
Areas Covered in the Session:
  • Assessing the eligibility of a product for an expedited approval pathway: drugs, biologics and medical devices
  • Best practices for format, style, and organization of the each type of expedited approval pathway
  • Best time in the development timeline to apply for each designation
  • Pros and cons of applying for each designation
  • What to do when a given designation is rejected: general processes to re-apply and appeal
  • Managing public information related to each expedited approval pathway
  • Common errors and potential solutions
Why should you attend:
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This webinar, presented by a leading regulatory affairs expert in expedited approval pathways, discusses all the expedited approval pathways available for FDA regulated products. Scope, process to obtain, and key strategies to maximize benefit will be discussed with case studies and examples from the experts extensive experience. The seminar will highlight best practices for using each expedited approval pathway, dos and don’ts, common issues, and potential solutions. Successfully tested strategies for format, tone, organization, and presentation of each expedited approval pathway will be discussed. The training is designed to provide a well-rounded training to all stakeholders in expedited approval pathways for FDA regulated industry.
Who will benefit:

This webinar will provide valuable assistance to all personnel in: 
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Project Managers
  • Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in drug and biologics products
Date: April 15, 2019
​Duration: 90 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com