Tag Archives: clinical investigator

FDA’s New Guidances for February 2013

Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease Class II Special Controls Guideline: Temporary Mandibular … Continue reading

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FDA’s New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro … Continue reading

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Across the Board Disqualifications for Clinical Investigators

The FDA issued a final regulation earlier this week (April 30th) that broadens the rules for clinical investigator disqualifications. Continue reading

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Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success.  Large organizations understand the value that project management can contribute to a successful project.  The smaller companies tend to … Continue reading

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August 2011 FDA Guidances

Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading

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