Here's an opportunity to get all the details in a new report available from FDAnews.
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 chemical entities (NCEs)/new molecular entities (NMEs)
Changes to previously approved drugs
Changes in dosage form, strength or route of administration
Changes from prescription (Rx) indications to over-the-counter (OTC) indications
Substitution of an active ingredient in a combination product
Of course, the devil is in the details — and that's why this report with valuable tips from Kurt Karst, Director with Hyman, Phelps & McNamara,and a widely respected legal authority and blogger on 505(b)(2) issues — is a must have. Readers will learn:
How the 505(b)(2) is similar to and differs from the 505(b)(1) standard NDA and the 505(j) ANDA
How drugs approved under the 505(b)(2) process can obtain either three or five years of patent exclusivity
When applications involving changes to approved drugs can use the 505(b)(2) pathway
How to choose a listed drug for a 505(b)(2) application
About FDA interpretations of the law affecting 505(b)(2) applications
About fees and restrictions involved in using the 505(b)(2) process
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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.
Drug company executives
Regulatory affairs officers
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