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and require the applicant to file a new submission and pay an additional fee according to the latest Agency draft guidance.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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FDA eCTD Review Process Q&A

Earlier this week, GlobalSubmit and Cato Research held an educational webinar on the FDA eCTD Review Process. The purpose of the webinar was to provide an overview of the various steps and stages that a drug application goes through in order to be approved by the FDA and marketed in the United States. During the webinar, GlobalSubmit’s CTO Jason Rock discussed the FDA’s workflow, the challenges they face in the electronic...

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FDA Statistics on NDAs, INDs and ANDAs

This year’s DIA annual meeting was more of a checkpoint rather than revealing startling new information – at least in the eSubmissions area. However, a lot of interesting information was exchanged. Today, I’ll focus on the FDA’s presentations. I’ll follow up later with information from other authorities and industry. Gary Gensinger provided his usual update on eSubmissions at the FDA: In the CDER town hall meeting, Gary noted that FDA...

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Minor Changes to FDA Electronic Submissions Guidance

On June 11th, 2008, FDA issued a Revision 2 of “Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” (http://www.fda.gov/cder/guidance/7087rev2.pdf). The previous version, Revision 1, dated from April 2006. So what’s new? Very little. The updates are all administrative in nature, and basically consist of:...

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