Searching Content indexed under Food and Drugs Law by T. Reed Stephens ordered by Published Date Descending.
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First Of Its Kind: Drug Wholesaler Accepts DPA And Two Executives Face Criminal Charges In SDNY For Illegal Distribution Of Opioids
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC),
United States
22 May 2019
Health Care Enforcement Quarterly Roundup | Q4 2018
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond.
United States
8 Feb 2019
Health Care Enforcement Quarterly Roundup Q3 | September 2018
In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months.
United States
9 Oct 2018
Health Care Enforcement Quarterly Roundup - July 2018
Over the past 18 months, we have closely monitored the Trump administration's approach to health care enforcement issues, with a particular focus on whether prosecution of the False Claims Act (FCA) ...
United States
25 Apr 2018
DOJ Leadership Reaffirms Expanded Enforcement Of The FCA To Combat Opioid Epidemic
In his March 2018 confirmation hearing, President Trump's nominee to head DOJ's Civil Division, Joseph "Jody" Hunt, signaled that DOJ would continue with its aggressive enforcement of the FCA.
United States
23 Apr 2018
Amarin Ruling Solidifies Off-Label Marketing Options But Raises Questions About False Claims Act Enforcement Action
While the Amarin decision is welcome news for the industry, drug manufacturers must still take care to analyze promotional statements to ensure that the content can be successfully defended as "truthful" and "non-misleading" speech.
United States
20 Aug 2015
Third Circuit Decides Long-Awaited Antidepressant Drug Labeling Preemption Cases
Manufacturers of antidepressant drugs are shielded from state failure-to-warn liability on the unique facts of FDAs repeated, intensive and public oversight of antidepressant drug labeling; questions about the scope of FDA preemption in broader contexts remain open.
United States
23 Apr 2008
FDA Issues Proposed Regulations On Supplemental Applications For Labeling Changes
Proposed Rules would codify FDAs long-standing view underscoring the circumstances that justify unilateral changes to labeling by the holder of the approved application.
United States
28 Jan 2008
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