Tag Archive: validation

Oct 24 2012

Considerations for the Assessment of Pain in Non-Verbal and Pediatric Subjects

Studies of drugs, biologics or devices that are intended for use in pediatric populations fall under far more stringent guidelines than those intended for use in adults.  The issues with pediatric studies range from informed consent concerns to stricter risk-to-benefit analyses.  Another problem that can arise in these studies, is that very young children cannot …

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Oct 14 2011

New FDA Guidances – September 2011

Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug and Biological Products De Novo Classification Process (Evaluation of Automatic Class III Designation) (Draft) Self-Selection …

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May 16 2011

New FDA Guidances – April 2011

Once again, Cato Research Regulatory Scientist Cathy Anderson has compiled a list of the notable guidance documents that have been recently released by the FDA.  Here’s a summary of the guidances released in April 2011 (most links go directly to PDF documents).

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May 12 2011

Conference Recap – Biomarker World Congress 2011

  Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients.  Specifically, personalized medicine is dedicated to the concept hat the right drug is administered to the right patient at the right dose at the right time.  To get …

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Feb 11 2011

FDA Guidances – January 2011

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 January 2011 (links go directly to PDF documents).

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