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Jerri's Blog | Just another WordPress.com weblog

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Jerri's Blog | Just another WordPress.com weblog | jerribperkins.wordpress.com Reviews

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About | Jerri's Blog

https://jerribperkins.wordpress.com/about

Just another WordPress.com weblog. This is an example of a WordPress page, you could edit this to put information about yourself or your site so readers know where you are coming from. You can create as many pages like this one or sub-pages as you like and manage all of your content inside of WordPress. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). You are commenting using your Twitter account. ( Log Out.

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Former FDA Medical Officer; “an insider perspective” | Jerri's Blog

https://jerribperkins.wordpress.com/2009/05/07/former-fda-medical-officer-an-insider-perspective

Just another WordPress.com weblog. May 7, 2009. Former FDA Medical Officer; “an insider perspective”. Posted in FDA Expert. At 5:27 pm by jerribp1. One question consistently asked is will we be audited . If you are involved in clinical research, expect to be audited someday. What is new is the recent. IRB sting operation, which revealed that one of the 3, IRBs selected failed in responsibility. IT was not the FDA but the GAO who conducted this operation. The question is will FDA intensify IRB scrutiny?

3

New Era at FDA | Jerri's Blog

https://jerribperkins.wordpress.com/2009/05/14/new-era-at-fda

Just another WordPress.com weblog. May 14, 2009. New Era at FDA. Posted in FDA Expert. At 6:41 pm by jerribp1. Will FDA reverse itself? How will this re-evaluation affect medical device manufacturers? Medical device companies can expect more stringent approval criteria in the future. The rules and regulations at FDA traditionally tighten after a controversial decision and particularly when Congress becomes involved. Companies can no longer rely on what worked in the past. It’s a new era at FDA.

4

February | 2012 | Jerri's Blog

https://jerribperkins.wordpress.com/2012/02

Just another WordPress.com weblog. February 2, 2012. Former FDA Medical Officer perspective on latest FDA controversy. At 9:26 pm by jerribp1. Why would doctors and scientists sue FDA as reported in the Washington Post on January 30, 2012 over e-mail surveillance? What do they expect to win, their jobs? Will FDA reverse itself? How should sponsors of medical devices respond? Companies should take a futuristic look at the Agency. What worked in the past is unlikely to be successful tomorrow. FDA computers...

5

Former FDA Medical Officer perspective on latest FDA controversy | Jerri's Blog

https://jerribperkins.wordpress.com/2012/02/02/former-fda-medical-officer-perspective-on-latest-fda-controversy

Just another WordPress.com weblog. February 2, 2012. Former FDA Medical Officer perspective on latest FDA controversy. At 9:26 pm by jerribp1. Why would doctors and scientists sue FDA as reported in the Washington Post on January 30, 2012 over e-mail surveillance? What do they expect to win, their jobs? Will FDA reverse itself? How should sponsors of medical devices respond? Companies should take a futuristic look at the Agency. What worked in the past is unlikely to be successful tomorrow. You are comme...

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Just another WordPress.com weblog. February 2, 2012. Former FDA Medical Officer perspective on latest FDA controversy. At 9:26 pm by jerribp1. Why would doctors and scientists sue FDA as reported in the Washington Post on January 30, 2012 over e-mail surveillance? What do they expect to win, their jobs? Will FDA reverse itself? How should sponsors of medical devices respond? Companies should take a futuristic look at the Agency. What worked in the past is unlikely to be successful tomorrow. FDA computers...

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