November 2, 2022 Regulatory Affairs

Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?

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November 1, 2022 Life Science Consulting

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100),…

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October 28, 2022 Life Science Consulting

ProPharma Group’s Dr David Crome to Act as Compliance Monitor...

From April 2022, the MHRA has been developing a pilot programme for…

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October 26, 2022 Life Science Consulting

Your Vendor Audit Program: On-site or Remote / Virtual?

It is quite common that a sponsor company will outsource services to…

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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 20, 2022 Life Science Consulting

Clinical (IMP) Drug Supply…It’s Complicated

Things to consider and how to ease the process IMP Supply Management…

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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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