Understanding the FDA

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CMS and FDA
Date: 7/28/2011
Length: 2 minutes
Speaker(s): Howard Holstein
Sources: Stanford Biodesign
Description: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 7: "Can you tell us how CMS and FDA relate?"

Other Videos in Series

Advice for Innovators
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 6: "Do you have any advice for an innovator or company approaching the FDA?"
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CDRH vs. CDER
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 3: "How does CDRH operate in comparison to CDER?"
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CMS and FDA
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 7: "Can you tell us how CMS and FDA relate?"
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Device/Drug Combinations
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 4: "Give us a feeling for the regulation of device/drug combination products."
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External Influences on FDA
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA: Question 5: "Can you tell us about external pressures on FDA?"
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History of FDA
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA:
Question 1: "Can you walk us through the essential parts of the history of the FDA with respect to device regulations?" Watch More
Structure of FDA/CDRH
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA:
Question 2: "Can you give us a feeling for the structure of the FDA and where CDRH fits in?" Watch More

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