On July 9, President Obama signed the FDA Innovation and Safety Act (S3187) which reauthorized PDFUA and MDUFA, implemented the Generic Drug User Fee Act and the Biosimilar User Fee Act. All of these updated regulations have new, far-reaching consequences for all life sciences firms in the United States. Tune into our new webinar on Sept. 12 to learn the details!
Details:
Together these new regulations are called the “UFAs.” Key to PDUFA and GDUFA are mandates for electronic submission – very likely in the eCTD format. In additional MDUFA calls for mandatory Electronic Copy to replace one of the paper copies required for presubmissions and submissions to CDRH.
FDASIA is effective October 1, 2012. Many sponsors inexperienced in the various electronic submission requirements of FDAISA will have great difficulty in meeting the mandates, timelines and quality requirements.
Details:
Together these new regulations are called the “UFAs.” Key to PDUFA and GDUFA are mandates for electronic submission – very likely in the eCTD format. In additional MDUFA calls for mandatory Electronic Copy to replace one of the paper copies required for presubmissions and submissions to CDRH.
FDASIA is effective October 1, 2012. Many sponsors inexperienced in the various electronic submission requirements of FDAISA will have great difficulty in meeting the mandates, timelines and quality requirements.
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