Tag Archive: biomarkers

Dec 19

FDA: The Year in Review (2012)

On 10 Dec 2012, the FDA released a report titled, “FY 2012 Innovative Drug Approvals,” which discusses the FDA’s 2012 novel drug approvals and the focus on the advancement of regulatory science in to improve the drug approval process. Thirty-five novel drugs were approved by the FDA in 2012, matching the number of approvals in …

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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 07

FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

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 23

The CED Life Science Conference and Biotech’s Yellow Brick Road

The 21st annual CED Life Science Conference achieved its mission of cementing the Research Triangle Park as a hotbed for innovation and opportunity in biotech.  The 2012 CED LSC showcased local leaders like Victor Dzau, President and CEO of Duke University Health Systems, and former four-term North Carolina governor James B. Hunt, as well as …

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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 10

Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies

Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET.

Sep 08

August 2011 FDA Guidances

Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act (Draft) Design Considerations for Pivotal Clinical Investigations for Medical …

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May 12

Conference Recap – Biomarker World Congress 2011

  Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients.  Specifically, personalized medicine is dedicated to the concept hat the right drug is administered to the right patient at the right dose at the right time.  To get …

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May 05

Diabetes Research Strategic Plan

The media continually alerts us to the epidemic of diabetes in the world.  Diabetes is the seventh leading cause of death.  Worldwide in 2007 there were 246 million people diagnosed with diabetes, and an additional 79 million people are at risk of developing diabetes in the near future.  According to the National Institutes of Health …

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Nov 02

October 2010 FDA Guidances

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in October 2010 (links go directly to PDF documents).

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