FDA to Introduce New Validation Errors for Study Data
Oct18

FDA to Introduce New Validation Errors for Study Data

These requirements pertain to submission of clinical and non-clinical data for studies initiated after December 17, 2016 if you’re filing NDAs, BLAs, and ANDAs. For commercial INDs, the requirement starts after December 17, 2017. In the event an original submission was filed before the requirements went into effect, subsequent submissions (amendments, supplements, and reports) to these types of applications still must meet the requirements.

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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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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and require the applicant to file a new submission and pay an additional fee according to the latest Agency draft guidance.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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Free Webinar: Understanding the New FDA Validation Criteria

GlobalSubmit is offering a free educational webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT. During this discussion, we will focus on some of the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

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