Choose the Right Drug Approval Pathway - Webinar CD/Transcript

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Choose the Right Drug Approval Pathway: Is a 505(b)(2) the Way to Go?

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

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

  • 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 for your company to go? Don’t miss this valuable webinar CD and transcript.

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

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.