FDA IDE Guidance Offers Industry Important Clarity
Michael Causey, Editor & Publisher, eDataIntegrityReport.com In its August [...]
26
08, 2014
13
08, 2014
FDA Guidance Advises Device Makers to Think About Home-Use
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Medical devic [...]
5
08, 2014
FDA Spreads Regulatory Love Nationwide
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Detroit may b [...]
29
07, 2014
Time to Take a Closer Look at FDA MDDS Moves
Russ King, Managing Partner, Methodsense The FDA recently released a new draft [...]
14
07, 2014
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical imag [...]
24
06, 2014
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against M [...]
3
06, 2014
FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after [...]
20
05, 2014
Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer
This latest round of medical device warning letters is all about pushback. The F [...]
14
04, 2014
The Six C’s of Document Management Best Practices for Life Sciences
Implementing a best-practice solution for any quality process is essential to he [...]
25
03, 2014
Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products
Dennis Payton, Vice President of Product Marketing and Development, Expandable [...]
