Tag Archive: CDRH

Jul 02

New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be held in July is also listed below with a link to more information. Special Interest …

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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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Aug 29

Biomarkers: Where are We Today?

The 06 August 2012 announcement by researchers from Boston’s Brigham and Women’s Hospital reporting the identification of a blood biomarker that could lead to earlier diagnoses and perhaps an actual treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, was of great interest to me.  First, my brother-in-law, at the peak of his very …

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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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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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Feb 22

A Brief Update on FDA’s Re-evaluation of the 510(k) Process

Change is in the air.  No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S. First, a brief primer on the medical device approval process in the U.S.  Currently, all novel medical devices must be approved through a “de …

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Aug 23

CDRH Proposes Changes to the 510(k) Pathway

All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look in the mirror in 2009.  With this period of introspection now complete, it has just …

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Jul 01

Use A Detailed Development Plan to Secure Venture Capital

It’s a tough time to be asking for money.  Whether you’re a high schooler who needs cash to gas up the ride or a fledgling biotechnology company with a hot technology, there’s not much extra to go around.  In today’s stiflingly competitive biotechnology financing market an on-target presentation to a potential investor can make the …

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May 06

Device Advisory Committee Changes

If you don’t like how things are, change it!  You’re not a tree. – Jim Rohn Planning on attending an Advisory Committee meeting for a medical device in the near future?  If you’re a regular at them, you may soon notice something different.  The FDA’s Center for Devices and Radiological Health (CDRH) recently announced some …

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