Tag Archives: medical devices

The FDA Wants To Hear Patients’ Voices

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA commissioner on complex issues relating to … Continue reading

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New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on … Continue reading

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New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming … Continue reading

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New FDA Guidances for May 2013

FDA released 10 guidances in May, including two Q & A guidances, which I always find helpful (Charging for Investigational Drugs Under an IND and Expanded Access to Investigational Drugs for Treatment Use).  Additionally, as directed by FDASIA, a guidance … Continue reading

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New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering … Continue reading

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