Cut Drug Approval Time

Cut Drug Approval Time - Webinar CD/Transcript

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Cut Drug Approval Time: Is A 505(b)(2) the Right Way to Go

Yes, you can speed up your company's drug approval time — by using the 505(b)(2) process.

In fact, in 2012 nearly 50 percent more drugs were approved this way than by the traditional 505(b)(1) pathway.

Still afraid that a 505(b)(2) may not work for you, or unsure of how to use the 505(b)(2) process?

Here's an opportunity to get all the details — from a recognized expert.

In a nutshell, Section 505(b)(2) allows you to obtain approval of NDAs containing investigations of safety and effectiveness that were not conducted by or for your company, but for which the FDA has already  issued an approval.

Section 505(b)(2) was written to help sponsors like you. It says that new studies 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 studies (or smaller ones), cutting your costs and shortening your development time.

And, a 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from an existing or approved drug. 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 set 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? Order this valuable webinar CD and transcript set and find out.

  • 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.  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. Previously, he was a lobbyist for F. Hoffman-La Roche Inc.

Mr. Karst served as an articles editor for the American University Law Review, and in 1995, was awarded a Fulbright Scholarship for post-graduate studies in Germany. He has published in the American University Law Review, the Food and Drug Law Journal and Update, RAPS FOCUS and many other publications, and is co-author of the Food and Drug Law Institute's Drug and Biologic Approvals: The Complete Guide for Small Businesses — FDA Financial Assistance and Incentives.