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Tag Archives: manufacturing
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 … Continue reading
Posted in FDA, Industry News
Tagged FDA, guidance, humanitarian device exemption, manufacturing, medical devices, PMA, safety, validation
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Vendor Selection – All that Glitters is Not Gold
One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities. Several variables determine what makes a good outsourcing partner – … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged biotech, clinical trials, CMC, CROs, drug development, funding, IND, manufacturing, nonclinical research, outsourcing, pre-IND, regulatory affairs
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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In a recent post, John Johnson discussed the FDA’s draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics, particularly in the context of planning and designing a clinical trial.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) … Continue reading
Posted in Clinical Trials
Tagged adaptive design, adaptive trials, analytical testing, API, clinical supplies, clinical trials, drug product, FDA, guidance, labeling, manufacturing
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