Articles Emissary International is a contract clinical research organization (CRO). http://www.emissary.com/articles 2017-09-27T21:40:30-05:00 Joomla! - Open Source Content Management FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form 2009-02-24T11:33:05-06:00 2009-02-24T11:33:05-06:00 http://www.emissary.com/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance <div class="feed-description"><p> <span style="line-height: 1.3em;">In July 2008, FDA released a </span><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf" title="" style="line-height: 1.3em;">draft guidance</a><span style="line-height: 1.3em;"> to answer frequent questions about </span><a href="http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.doc" title="" style="line-height: 1.3em;">Form FDA-1572</a><span style="line-height: 1.3em;">, 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. </span><strong style="line-height: 1.3em;">Keep in mind that this is only a draft</strong><span style="line-height: 1.3em;">; with the recent change in administration this draft may never be released as final or it may be significantly modified.</span></p> <p class="feed-readmore"><a target="_blank" href ="/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance">Read More...</a></p></div> <div class="feed-description"><p> <span style="line-height: 1.3em;">In July 2008, FDA released a </span><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf" title="" style="line-height: 1.3em;">draft guidance</a><span style="line-height: 1.3em;"> to answer frequent questions about </span><a href="http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.doc" title="" style="line-height: 1.3em;">Form FDA-1572</a><span style="line-height: 1.3em;">, 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. </span><strong style="line-height: 1.3em;">Keep in mind that this is only a draft</strong><span style="line-height: 1.3em;">; with the recent change in administration this draft may never be released as final or it may be significantly modified.</span></p> <p class="feed-readmore"><a target="_blank" href ="/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance">Read More...</a></p></div> The Historical Rise of Pharmaceutical Regulation 2008-03-12T12:35:51-05:00 2008-03-12T12:35:51-05:00 http://www.emissary.com/articles/11-clinical-research-articles/clinical-research-professional/48-history <div class="feed-description"><p><span>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.</span></p> <p class="feed-readmore"><a target="_blank" href ="/articles/11-clinical-research-articles/clinical-research-professional/48-history">Read More...</a></p></div> <div class="feed-description"><p><span>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.</span></p> <p class="feed-readmore"><a target="_blank" href ="/articles/11-clinical-research-articles/clinical-research-professional/48-history">Read More...</a></p></div>