Tag Archive: marketing application

Sep 25

Time to Approval and the Metrics of Facilitated Regulatory Pathways

By Dr. Jack Snyder, RAC (US, EU, CA, GS), Asst. Managing Director and Clinical Research Physician at Cato Research “Early access pathways” for biomedical product marketing approval have attracted substantial attention recently, as Sarepta Therapeutics’ drug Exondys (eteplirsen) gained accelerated approval based on clinical data from just 12 patients.  In the United States, four “expedited” …

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Jul 13

New FDA Guidances for May and June 2016

By Yuka Fukushima, Regulatory Associate & Compliance Specialist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH from May-June 2016, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Early Clinical Trials With …

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Feb 02

New FDA Guidances for January 2016

Special Interest Guidances/Information Date Posted Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices– Draft Guidance 26-Jan-2016 Postmarket Management of Cybersecurity in Medical Devices- Draft Guidance 22-Jan-2016 Guidance Agenda: Guidances CDER is Planning 22-Jan-2016 Implanted Blood Access Devices for Hemodialysis– Final Guidance 21-Jan-2016 Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions …

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Dec 01

New FDA Guidances for November 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in November 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Certification Process of Designated Medical Gases …

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Aug 04

New FDA Guidances for July 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in July 2015, are posted.  In addition, upcoming advisory committee meetings to be held in September are also listed below with a link to more information. Special Interest Guidances/Information Date Posted Dissolution Testing and Specification …

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Jun 29

Credentialing Developments at Cato Research

In 2014, approximately 20-25 members of the global CATO staff participated in extensive training sessions devoted to Canadian Regulatory Affairs. This effort was led by Amelie Rodrigue-Way, PhD from the Montreal office of CATO Research Ltd. During the last 8 months, one of the tangible and visible results of this training has been the successful …

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Jun 01

New FDA Guidances for May 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information. Also, as we strive to keep you updated on …

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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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Jul 20

FDASIA, Part 1: The “UFAs”

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 series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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May 21

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, there is only one approved stem cell product on the market in the United States …

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