Facet Life Sciences Holiday Gift Guide: Because Even Santa Needs Regulatory Expertise!
Facet Life Sciences Holiday Gift Guide: Because Even Santa [...]
Getting To and Through FDA with Bill Hodnick
We recently caught up with Bill Hodnick, Product Development [...]
FDA Meetings: When More Meetings are a Good Thing!
Most of us are trying to simplify our schedules and [...]
The Sky is Not Falling: Product Development Can and Should Progress During The Government Shut Down!
The effects of the U.S. government shut down and the [...]
DMS, Document Sharing & eRoom Technologies: What’s Right For You?
By Ken VanLuvanee Recently in our conversations with sponsors, we’ve [...]
The Myth of Being Special
by Lisa Jenkins VanLuvanee I believe that people are special. [...]
Developing Therapies In a Lean Organization Using On Demand Expertise
By Ken VanLuvanee There appear to be two diverging strategies [...]
The Future of Post-Approval Change Management
Reproduced with permission from DIA North America. You can see [...]
Electronic Requirement, Are You Ready?
The Food and Drug Administration Safety and Innovation Act (FDASIA) [...]
PDUFA User Fees- Impact On Your Submission
PDUFA USER FEES – IMPACT ON YOUR SUBMISSION The Prescription [...]
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