Tag Archive: harmonization

Feb 08 2013

The Changing Landscape of Postmarketing Safety Reporting

Drugs are approved for marketing on the basis of clinical trials that are, generally speaking, carried out on relatively small numbers of people.  The goal of these trials are to identify the risks inherent in taking a drug while also assessing the drug’s efficacy in the treatment of the intended indication.  However, once a drug …

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Jul 27 2012

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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