Tag Archive: adverse events

Jul 09 2012

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 a code, similar in theory to a barcode, that will be printed on each device …

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Jul 28 2011

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 predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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Jun 10 2011

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 Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” which became …

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May 26 2011

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.

May 18 2011

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 for the final rule was to improve monitoring of adverse events (including those from BA/BE …

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Apr 28 2011

Statistical Reviews of Case Report Forms

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. The project statistician also has a clearer view of how the data will affect the …

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Jan 20 2011

Is it an Adverse Event or an Adverse Drug Reaction?

The ICH E6 guideline offers clear definitions for adverse events (AEs) and adverse drug reactions (ADRs). AEs are considered to be any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. ADRs, on the other hand, consist of …

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Jan 14 2011

FDA Guidances – December 2010

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in December 2010, including a few from the first week of January 2011 as well (links go directly to PDF documents).

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Sep 27 2010

Annual Reports: A Time for Reflection

You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year?  Quite possibly.  In the rush to keep things moving, it’s all too easy to not take the time to pause and get a healthy dose of perspective.  Enter annual reports for drug/biologic development …

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Jun 18 2010

DIA 2010 – Week in Review

The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location.  In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas of the Agency. As previously mentioned, Will Lee and I attended the meeting.  For those …

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