Ban on Titanium Dioxide (E171) on the EU Food Market:...
Use of Titanium Dioxide in the EU Food Market In 2021, the…
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FDA Accelerated Approval Pathway: A Potential Missed Opportunity for Sponsors
The accelerated approval provisions of FDASIA in section 506(c) of the FD&C…
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What You Need to Know About Developing Vaccines
An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may…
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Prescription Drug User Fee Act (PDUFA) VII and Type D...
For those who have been awaiting Congressional reauthorization of PDUFA, the wait…
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What You Need to Know About CBER Pre-IND Meetings
The FDA provides several opportunities to hold meetings with Sponsors to gain…
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CAR-T Cells: Challenges, Lessons Learned, and Guidance for the Clinical...
It comes as no surprise to any pharmaceutical or biotech company that…
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How to Comply with the Nitrosamine Regulations for Your New...
Introduction: Are you in the development phase for your medicinal product? Have…
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FDA Announces Availability of Multiple Draft Guidances – Drug Information...
Today, FDA announced the availability of the following draft guidances for industry,…
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