Tag Archives: postmarketing

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 … Continue reading

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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: … Continue reading

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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: … Continue reading

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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 … Continue reading

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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 … Continue reading

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