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The Information Source for Regulated Domestic and International Small Pharmaceutical Business
Bioresearch Monitoring Information System (BMIS) Data In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring Web site that makes clinical research information available to the public. This Web site contains information that identifies clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics. This information is extracted from IND-related documents submitted to the agency and made available to the public as the Bioresearch Monitoring Information System (BMIS) at http://www.accessdata.fda.gov/scripts/cder/bmis/. CDER recently became aware that the BMIS dataset does not contain clinical investigator information from all IND studies reviewed by CDER. Specifically, data from submissions received in electronic format are not included in the publicly searchable information. As a result, BMIS reflects only a portion of the information CDER received from sponsors regarding clinical investigators participating in their trials. CDER is aware that data from the BMIS database are being used to analyze trends in clinical research. CDER has begun the process of changing the BMIS data entry procedures to include documents submitted in electronic format, in order to provide the public with a more comprehensive picture of the information the agency receives. BMIS is not intended to provide a comprehensive list of all clinical investigators, CROs or IRBs involved in CDER-regulated clinical research. Although CDER is changing some procedures to make the BMIS list more comprehensive, these changes will not address two data limitations described below. The database includes only investigators engaged in research of CDER-regulated drugs and biologics under an IND, for whom FDA has received a Form FDA 1572. This leads to the following limitations important for BMIS data analysis: - Although the sponsor is required to collect the 1572 from each clinical investigator in a trial conducted under FDA’s IND regulations, FDA does not require the form itself to be submitted to the agency. Many sponsors submit the 1572 to FDA, however, because the form collects, in one place, information that must be submitted to FDA in some fashion under our IND regulations. - A sponsor may choose, but is not required, to conduct a foreign clinical study under an IND. If a clinical study is conducted outside of the United States and is not conducted under an IND, then the investigator need not sign a 1572. Please find additional information at: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135162.htm
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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