|
Court deals blow to mysteriously named whistleblower, blowing off precedent
October 17, 2017
|
|
When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm
September 19, 2017
|
|
Is the 510(k) process as worthless as the federal courts seem to believe?
August 8, 2017
|
|
The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials
July 27, 2017
|
|
Congress Seeks a Statutory Fix to Stymied Off-Label Discussions
May 2, 2017
|
|
DOJ Uses False Claims Act to Enforce FDA Manufacturing Rules
April 7, 2017
|
|
LDTs: The Saga Continues
April 2017
|
|
The Problem of the ‘Intended Use’ Regulations Continues to Fester
March 21, 2017
|
|
A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts
November 29, 2016
|
|
Show more firm publications
|
|