Articles http://www.zachmayo.com/articles Mon, 23 Oct 2017 13:53:10 -0500 Joomla! - Open Source Content Management en-gb FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form http://www.zachmayo.com/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance http://www.zachmayo.com/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance

 In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. Keep in mind that this is only a draft; with the recent change in administration this draft may never be released as final or it may be significantly modified.

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Featured Focus on Clinical Research Professionals Articles Tue, 24 Feb 2009 11:33:05 -0600
The Historical Rise of Pharmaceutical Regulation http://www.zachmayo.com/articles/11-clinical-research-articles/clinical-research-professional/48-history http://www.zachmayo.com/articles/11-clinical-research-articles/clinical-research-professional/48-history

The first rumblings for US drug legislation began after the Civil War, which had spurred the separation of drug manufacturers from drug prescribers and drug dispensers. This was the time of the traveling medicine shows selling dangerous, addictive or just non-sense patent medicines. Today's pharmaceutical companies got their start in the apothecary shops of that time, but still, most drugs were imported from Europe. In fact the U.S was a dumping ground for substandard and contaminated drugs.

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Featured Focus on Clinical Research Professionals Articles Wed, 12 Mar 2008 12:35:51 -0500