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Regulatory Affairs Blog Posts

November 2, 2022 Regulatory Affairs

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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October 25, 2022 Regulatory Affairs

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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October 19, 2022 Regulatory Affairs

What You Need to Know About Developing Vaccines

An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may…

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October 12, 2022 Regulatory Affairs

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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September 27, 2022 Regulatory Affairs

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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September 20, 2022 Regulatory Affairs

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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September 14, 2022 Regulatory Affairs

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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August 26, 2022 Regulatory Affairs

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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