The Center for Drug Regulation and Research is currently in the process of improving its old record system to a paperless/electronic storage. As part of the transition. retrieval of previously submitted documents has become one of the major impediments in meeting the committed turn-around time for the processing of (1) compliances to Notice of Deficiencies/Letter of Abeyance issued to initial, renewal (Regular and Automatic Renewal), and amendment applications, (2) revalidation applications for pharmaceutical products granted conditional approval (i.e.. one year validity). and (3) re-applications.

 To avoid further delays and facilitate the processing of the abovementioned applications, please submit electronic copies (e-copies) of your previously-filed application dossiers or "old file" (e.g., for compliances and re-applications, the initially submitted application dossier: for renewal and revalidation applications, the last approved dossier).

 This initiative will also aid in the merging of already submitted e-copies pursuant to FDA Memorandum Circular No.2013-023 and FDA Memorandum Circular No.2014-001.

 

Please coordinate with Mr. Manuel P. Dulzo for your submission.

 Thank you very much for your usual support and cooperation.

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