Tag Archives: adverse events

Unique Device Identifiers: It’s the Law, Almost

When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system.  On 03 July 2012, the FDA released the proposed rule for UDIs. The UDI is … Continue reading

Posted in FDA, Industry News | Tagged , , , , , , | 2 Comments

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet … Continue reading

Posted in Clinical Trials, FDA, Industry News | Tagged , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off on Imaginary patients, Imaginary data, et Cetero, et Cetero…

Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading

Posted in Clinical Trials, Webinars | Tagged , , , , , , , , , | Comments Off on Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals. Continue reading

Posted in Clinical Trials, Conferences and Meetings | Tagged , , , , , , , , , , , , , , , , , , , , , , | Comments Off on Conference Recap – 2011 ACRP Global Conference and Exhibition

FDA Enforcement of New IND and BA/BE Safety Reporting Requirements

FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011.  FDA’s intent … Continue reading

Posted in Clinical Trials, FDA, Industry News | Tagged , , , , , , , , | 1 Comment