Articles Emissary International is a contract clinical research organization (CRO). http://rc.sendemissary.com/articles/11-clinical-research-articles/clinical-research-professional 2017-10-24T03:22:45-05:00 Emissary.com smayo@emissary.com 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://rc.sendemissary.com/articles/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance <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draft guidance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 ="">Read More...</a></p> <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draft guidance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 ="">Read More...</a></p> FDA’s Bioresearch Monitoring (BIMO) Inspections 2008-08-15T18:47:29-05:00 2008-08-15T18:47:29-05:00 http://rc.sendemissary.com/articles/11-clinical-research-articles/clinical-research-professional/59-bimo-inspections-in-2007 <img title="FDA BIMO inspections, Form 483 and Warning Letter" style="margin: 15px 20px 15px 0px" alt="FDA BIMO inspections, Form 483 and Warning Letter" src="/images/stories/BIMO_Inspections.gif" width="175" align="left" border="2" height="215" /> <p><strong>BIMO, the Bioresearch Monitoring Program, </strong>is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics. Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CR0s working under the sponsor). </p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <img title="FDA BIMO inspections, Form 483 and Warning Letter" style="margin: 15px 20px 15px 0px" alt="FDA BIMO inspections, Form 483 and Warning Letter" src="/images/stories/BIMO_Inspections.gif" width="175" align="left" border="2" height="215" /> <p><strong>BIMO, the Bioresearch Monitoring Program, </strong>is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics. Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CR0s working under the sponsor). </p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p>