Authors

Eric Evans

Document Type

Perspective

Publication Title

Emory Corp. Governance & Accountability Rev. Perspectives

Publication Date

1-1-2018

Abstract

In response to some of the most egregious abuses of the citizen petition process, pharmaceutical manufacturers who raise concerns via the petition process that relate to their own product's formulation, delivery system, or any other aspect should be estopped from continuing to market and sell their product as is. If a drug manufacturer files a 505(q) petition, the FDA should force the filing manufacturer to comply in regards to their own products with the suggested requirements they make for the generic competition.

First Page

115

Volume

5

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