FDA eCTD Mandate: One Year and Counting
May05

FDA eCTD Mandate: One Year and Counting

Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same. Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.

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FDA, Generic Industry Continue Quest for Higher-Quality ANDA Submissions
Jun17

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

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...

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Understanding GDUFDA

Representatives of the U.S. Food & Drug Administration have not minced words when talking about the effect of the Generic Drug User Fee Amendments (GDUFA). The law that established user fees in exchange for a more predictable review process has been called a “transformational change” on more than one occasion. The transformation is causing growing pains as the Agency chases higher quality Abbreviated New Drug Applications (ANDAs)...

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FDA to Postpone Major Electronic Initiatives
Dec10

FDA to Postpone Major Electronic Initiatives

The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.

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FDA Provides Clarification for Organizations Submitting ANDAs

The Generic Drug User Fee Amendments (GDUFA) introduced user fees to the organizations participating in the bioequivalent drug industry and incentivized filing Abbreviated New Drug Applications (ANDAs) electronically. The law functions as an informal mandate by promising expedited review times to applicants who submit to the US FDA in eCTD format. Another GDUFA stipulation addressed the Refuse-to-Receive (RTR) designation for ANDA...

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