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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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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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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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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Clinical (IMP) Drug Supply…It’s Complicated
Things to consider and how to ease the process IMP Supply Management…
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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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