Tag Archives: manufacturing

Clinical Trials with Chimeric Antigen Receptor T Cells (CAR-T cells)

By: William T. Lee, Ph.D., R.A.C., Vice President of Regulatory Affairs at Cato Research At the 2014 American Society of Gene and Cell Therapy Annual Meeting (ASGCT) held on May 21-May 24, all the buzz was focused on the astounding … Continue reading

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Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of … 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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FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: … Continue reading

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New FDA Guidances – December 2011/January 2012

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be … Continue reading

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