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Guidance on Refuse to Receive ANDAs for Lack of Impurity Info
08/25/2016
 

Federal Register Notice: FDA is making available a guidance for industry entitled Abbreviated New Drug Application Submissions — Refuse to Receive for Lack of Justification of Impurity Limits. It is intended to assist applicants preparing to submit to FDA ANDAs and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive an ANDA. To download this guidance, click here. To view this notice, click here.

 
 
 
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