FDA, Generic Industry Continue Quest for Higher-Quality ANDA Submissions

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The FDA’s Activities Report of the Generic Drug Program for May 2014 reveals that Refuse to Receive (RTR) notifications equaled Approvals at 20 (see complete chart below). The numbers will almost certainly come as a disappointment considering the attention being paid to improving the quality of ANDA submissions by sponsors of generic drug applications and the Office of Generic Drugs (OGD).

This week the FDA published yet another draft guidance intended to address quality as part of its overall initiative to overhaul the submission and approval process for generic drug applications. GDUFA, or the Generic Drug User Fee Amendments, was the catalyst for changes the generic drug industry is now grappling with. GDUFA is set for full implementation later this year (please reference the chart below for performance goals).



ANDA Submissions – Content and Format of Abbreviated New Drug Applications does not provide guidelines for eCTD compilation and submission, which are not yet mandatory for ANDA sponsors. Step-by-step content instructions for each module of the CTD are included. Quoting from the notice accompanying the document:

“The guidance document is intended to assist applicants in preparing complete and high-quality original [ANDAs] for submission to FDA under the [FDC Act]. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. The guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information in each section of the application.”

A pre-recorded webinar explaining the draft guidance was also made available by the FDA.

Communications surrounding ANDA submissions have been numerous in the past year. FDA has published RTR standards and a public docket for industry to submit input and suggestions on ways to improve ANDA quality as well as how to best communicate those suggestions to the generic drug industry.

Concerns and suggestions submitted to the public docket such as access to RTR summaries, ANDA filing checklist confusion and inconsistent individual review were not addressed in the most recent guidance document.

Author: GS

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