Tag Archive: FDA Guidances

Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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Apr 10 2019

2019 March FDA Guidances

Special Interest Guidances/Information Date Posted Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice – Final Guidance 27 Mar 2019 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Final Guidance 25 Mar 2019 Rare Diseases: Natural History Studies …

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Mar 03 2014

New FDA Guidances for February 2014

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in February, are posted.  In addition, the upcoming Advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Special Interest Guidances/Information Date Posted Distributing Scientific and …

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Dec 05 2013

New FDA Guidances for November 2013

There were plenty of interesting releases from FDA in November.  Near and dear to my own research heart was the finalization of the guidance for the Preclinical Assessment of Investigational Cellular and Gene Therapy Products.  Also, if you’re interested in a scathing read, check out FDA’s warning letter to genetic testing company 23andMe.  The company …

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