Articles by Benjamin Danso - Pharmaceutical Technology

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Articles by Benjamin Danso

Benjamin Danso


Benjamin Danso, Pharm.D., is regulatory project manager at FDA, CDERs Office of Generic Drugs.

A Survey of Postapproval CMC Changes to Generic Drugs
March 2, 2014

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
30%
Breakthrough designations
9%
Protecting the supply chain
39%
Expedited reviews of drug submissions
9%
More stakeholder involvement
13%
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Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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