Expedited Approval Pathways in the US: Best Ways to Get the Most Incentives

Date: April 14, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
  1. Assessing the eligibility of a product for an expedited approval pathway: drugs, biologics and medical devices
  2. Best practices for format, style, and organization of each type of expedited approval pathway
  3. Best time in the development timeline to apply for each designation
  4. Pros and cons of applying for each designation
  5. What to do when a given designation is rejected: general processes to re-apply and appeal
  6. Managing public information related to each expedited approval pathway
  7. Common errors and potential solutions

Why should you attend:
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: 
  1. Regulatory affairs professionals
  2. Senior management executives (CEO, COO, CFO, etc)
  3. Project Managers
  4. Clinical trial specialists
  5. Regulatory Compliance Associates and Managers
  6. People investing in drug and biologics products

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com