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 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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US FDA Refuse-to-Receive Guidance for Electronic ANDA Submissions

Serious deficiencies in Abbreviated New Drug Applications (ANDAs) will trigger a refuse-to-receive response from the U.S. Food & Drug Administration, and require the applicant to file a new submission and pay an additional fee according to the latest Agency draft guidance. Enhanced refusal-to-receive standards are one of the primary Year 1 program goals under the Generic Drug User Fee Act (GDUFA) which initiates a user fee...

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