FDAnews Announces — Choose the Right Drug Approval Pathway: Is a 505(b)(2) the Way to Go? Webinar, March 24, 2016

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A 505(b)(2) product could receive fast-track approval, especially for products with limited changes from existing or approved drugs. This webinar is led by an acknowledged expert, Kurt Karst, who is a Director with Hyman, Phelps & McNamara, and a widely respected legal authority and blogger on 505(b)(2) issues.

Choose the Right Drug Approval Pathway:
Is a 505(b)(2) the Way to Go?
March 24, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/rightdrugapprovalpathway

Section 505(b)(2) was written to help sponsors.

For example new and costly trials that duplicate studies already performed on a reference drug may not be necessary. So, a company could get a break and only have to provide a limited number of clinical studies (or smaller ones) — or none at all — cutting costs and shortening development time.

And, a 505(b)(2) product could receive fast-track approval, especially for products with limited changes from existing or approved drugs. Ideal candidates include:

  •     New indications
  •     Changes in dosage form, strength, formulation, dosing regimen or route of administration
  •     New combination products
  •     New active ingredients
  •     Prodrug of an existing drug

Of course, the devil is in the details — and that's why this FDAnews webinar is led by an acknowledged expert. Kurt Karst is a Director with Hyman, Phelps & McNamara, and a widely respected legal authority and blogger on 505(b)(2) issues. He will teach attendees:

  •     To understand the nuances and shifts in the development of the 505(b)(2) route to approval, from FDA’s pre-1984 “Paper NDA” policy to the current statute
  •     Current FDA interpretations affecting 505(b)(2) applications
  •     Pitfalls to avoid (and potential opportunities to capitalize on) in the 505(b)(2) space
  •     How to choose the appropriate listed drug
  •     How to understand patent certification and potential exclusivities
  •     Secrets to interpreting new legal challenges to the 505 process, including citizen petitions, looming lawsuits and the assignment of therapeutic equivalent codes

There's only one way to answer the question posed in this webinar's title — is a Section 505(b) (2) the right way to go? Don’t miss this valuable webinar.

Meet the Presenter:
Kurt Karst, a Director with Hyman, Phelps & McNamara, is a widely respected legal authority and blogger on 505(b)(2) issues. Mr. Karst provides regulatory counseling to pharmaceutical manufacturers concerning Hatch-Waxman patent and exclusivity issues, myriad drug development issues, pediatric testing issues, and orphan drug issues.

Who Will Benefit:

  •     Legal counsel
  •     Regulatory affairs
  •     Compliance officers
  •     Product lifecycle managers

Webinar Details:
Choose the Right Drug Approval Pathway:
Is a 505(b)(2) the Way to Go?
March 24, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/rightdrugapprovalpathway    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/rightdrugapprovalpathway
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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