FDLI Publications - Monograph Volume 1, Number 6

FDLI Monograph Series
Volume 1, Number 6

The 505(b)(2) New Drug Application Process:
The Essential Primer
Alan Minsk, Partner, Arnall Golden Gregory LLP
Lanchi Nguyen, Associate, Arnall Golden Gregory LLP
Diana Rusk Cohen, Associate, Arnall Golden Gregory LLP

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About This Monograph

The old saying “time is money” is especially relevant for drug manufacturers who are
often racing against the clock, and each other, to obtain approval for and bring new drug
products to the market. In this context, the 505(b)(2) new drug application (NDA) is a
potentially appealing regulatory pathway for many manufacturers. As one of three types
of new drug applications, the 505(b)(2) NDA allows drug companies to obtain Food and
Drug Administration (FDA) approval of essentially “new” drugs without having to conduct
the full complement of safety and efficacy trials, which is often the most time-consuming
and expensive part of the drug development process. Because the 505(b)(2) NDA permits
the drug manufacturer to rely on the agency’s findings for a previously-approved drug,
published literature, or both, the typical 505(b)(2) application seeks to obtain approval for a
modification of a previously-approved drug product, such as a change in dosing regimen, a
new active ingredient or a new indication for use.

Drug sponsors (and their legal counsel) must understand how to evaluate the
potential benefits of using the 505(b)(2) application and anticipate possible problems.
Often, companies perceive that the FDA review process will proceed quickly with a reduced
requirement for amount of clinical data, but they fail to anticipate and avoid delays in the
process, which can potentially turn the submission of a 505(b)(2) into a full-fledged, de facto
full NDA. In summary, this Monograph will help manufacturers weigh costs and benefits
(in terms of time and money) by clarifying the 505(b)(2) NDA regulatory pathway. The
Monograph discusses the underlying statutory and regulatory provisions, analyzes how
FDA applies these provisions and explains the potential advantages and disadvantages of the
505(b)(2) NDA process.

This Monograph is not intended to be a treatise or offer legal advice and cannot cover
every nuance of the law and guidance. Moreover, it cannot predict how FDA will evaluate a
particular product. Rather, it is offered to explain the law, issues to consider when deciding
whether to pursue a 505(b)(2) regulatory strategy, and benefits and limits of such an
approach. Each case is fact-specific, but this Monograph attempts to identify the important
issues and describe potential pitfalls to minimize delays and surprises.

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FDLI Monograph Series Volume 1, Number 6