Tag Archive: drug product

Jun 06 2012

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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Nov 02 2011

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 lag behind and often do not recognize that project management is not too complex or …

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Jan 17 2011

New Informed Consent Requirements Improve Transparency in Clinical Trials

Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with their amended informed consent regulations. The new regulations stem from the Food and Drug Administration …

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Jun 23 2010

Adaptive Designs and Clinical Supplies

In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.  My perspective concerns challenges related to clinical supplies (CS) presented by adaptive trial designs. FDA defines an adaptive design clinical study as “a study …

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