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Posted 01 May 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements.
FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs, posted 27 April, describes how ANDA supplement sponsors "may ask FDA to expedite its review of a supplement if a delay in making the change described in it would impose an extraordinary hardship on the applicant."
In such cases, applicants are advised to fill out an Expedited Review Request form to submit with their supplement application.
FDA said in its MAPP that is recognizes that situations arise in which sponsors require an expedited review, either because of extraordinary hardship, mitigate public health needs or meet "the government's best interest."
These requests will be considered on a "case-by-case basis," and only when the Expedited Review Request form accompanies the application.
Scenarios meeting the "extraordinary hardship" for sponsors include recovering from catastrophic events and unforeseeable events such as supply chain disruptions or the abrupt need to relocate a facility.
Public health and governmental needs include drug shortages, issues relating to non-substitutable drugs, products related to government drug-purchasing programs and legally-mandated actions.
In the event that a sponsor does not receive a favorable response to their expedited review request, they may appeal the decision, and are advised to provide supporting documentation along with their request to appeal. All appeal decisions are final.
MAPP - 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs
Tags: Extraordinary Hardship, Appeal, Expedited Review Request, Supplement, MAPP, ANDAs, OGD, ANDA, Latest News, staff
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