Tag Archives: marketing application

Time to Approval and the Metrics of Facilitated Regulatory Pathways

By Dr. Jack Snyder, RAC (US, EU, CA, GS), Asst. Managing Director and Clinical Research Physician at Cato Research “Early access pathways” for biomedical product marketing approval have attracted substantial attention recently, as Sarepta Therapeutics’ drug Exondys (eteplirsen) gained accelerated … Continue reading

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New FDA Guidances for May and June 2016

By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from May-June 2016, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below … Continue reading

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New FDA Guidances for January 2016

Special Interest Guidances/Information Date Posted Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices– Draft Guidance 26-Jan-2016 Postmarket Management of Cybersecurity in Medical Devices- Draft Guidance 22-Jan-2016 Guidance Agenda: Guidances CDER is Planning 22-Jan-2016 Implanted Blood Access Devices for … Continue reading

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New FDA Guidances for November 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in November 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a … Continue reading

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New FDA Guidances for July 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted.  In addition, upcoming advisory committee meetings to be held in September are also listed below … Continue reading

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