Tag Archive: CBER

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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Jul 14

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

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Mar 14

2010 New Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.

While the list isn’t long, a few new products stand out to me.

Aug 10

Bookmarks – Collapsed or Expanded?

At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened).  We’re often asked if there is a specific reason that we do this, since the FDA eCTD guidances …

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May 19

FDA Forms Biosimilar Work Group

In the end we are all separate: our stories, no matter how similar, come to a fork and diverge. We are drawn to each other because of our similarities, but it is our differences we must learn to respect. – Unknown As I’ve mentioned before, the recent healthcare reform act (technically the “Patient Protection and …

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Apr 21

FDA-TRACK – The FDA’s FDA-Tracking System

Data is what distinguishes the dilettante from the artist. – George V. Higgins In another move on its transparency initiative, the FDA has recently announced a new program to publicly track its own performance.  It’s called FDA-TRACK and, in the FDA’s own words, its objectives are: Transparency – provide interested parties an unprecedented look into …

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