Tag Archive: manufacturing

Jun 25

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 results from clinical trials with chimeric antigen receptor T cells (CAR-T cells). These CAR-T cells …

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Jan 30

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 a drug and a device; a biological product and a device; a drug and a …

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Dec 06

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 Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Dec 06

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 Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Aug 15

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: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Feb 20

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 found in this previous blog post) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications …

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Nov 29

Fifth China Medicinal Biotech Forum – Conference Recap

I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011.  The purpose of this conference was to update graduate students in China on the latest trends in biotechnology.  This forum also allowed scientists from Europe, Australia, Japan, US, and South America to collaborate with Chinese colleagues at …

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Nov 02

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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Aug 11

Divisive Devices or UFC 510(k): FDA Meets IOM

In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices.  This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by industry complaints about the review process, arguments over the safety of cleared devices, and a …

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Jul 18

New Guidances from FDA – June 2011

Guidance

Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (Draft) …

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