Regulatory Focus™ > News Articles > Owe FDA Money? Don't Bother Submitting an Application, Says CDER

Owe FDA Money? Don't Bother Submitting an Application, Says CDER

Posted 19 April 2012 | By Alexander Gaffney, RAC 

A new Manual of Policies and Procedures (MAPP) document issued by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) notes that if a pharmaceutical manufacturer is in arrears to FDA, CDER "shall refuse to accept the application for filing."

FDA's MAPP 60.50.1 Rev. 1, Refusal to Accept Applications for Filing From Applicants in Arrears, notes "It is the general policy of CDER that human drug applications and supplements will be accepted for filing only from applicants (including their affiliates) who have paid all prescription drug user fees owed."

Applicants can find themselves in arrears to FDA by having unpaid fees to FDA's Office of Financial Management (OFM) or by failing to submit user fees to OFM within 5 days of a payment being due for a submission.

"When OFM determines that an applicant is in arrears for such owed fees, the review division to which an application is submitted shall refuse to accept the application for filing," concludes FDA.


Read more:

FDA - MAPP 60.50.1 Rev. 1, Refusal to Accept Applications for Filing From Applicants in Arrears


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