06c1c8ee-6564-46fe-9989-dbf4fbf086fe_1531776 - ... Direct

Feature: The Strategy of Delay — Understanding FDA Citizen Petitions

Even if the petition is ultimately denied, the delay can preserve the brand's monopoly for months, translating into significant additional revenue. 3. Legislative Countermeasures 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...

Allows the FDA to summarily deny petitions that are deemed to be submitted solely for the purpose of delay. 4. Current State of Play Feature: The Strategy of Delay — Understanding FDA

The core issue discussed in the SSRN study (ID 1531776) is whether brand-name manufacturers use these filings strategically. 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...

Prevents the FDA from delaying the approval of a generic drug unless a delay is necessary to protect public health.