Tag Archive: postmarketing

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 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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Jul 27

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

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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Apr 09

New FDA Guidances Released in March 2012

Here’s a list of the notable guidances released by FDA in March 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program (Draft) Drug Safety Information — FDA’s Communication …

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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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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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Apr 08

New FDA Guidances – March 2011

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 March 2011 (most links go directly to PDF documents). Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act …

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Mar 30

Social Media in Clinical Trials: Increasing Patient Recruitment

Sources used to access health and wellness information

When you become sick with a virus or are seeking information about a diet, where’s the first place that you turn to for help? Is it the doctor’s office or the internet? A recent study showed that the percentage of American adults that had access to the internet rose from 46% in 2000 to 74% …

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Jan 14

FDA Guidances – December 2010

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 December 2010, including a few from the first week of January 2011 as well (links go directly to PDF documents).

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Aug 11

Accelerated Approval

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  What is accelerated approval and how does it work? The process is defined in 21 …

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