Searching Content indexed under Healthcare by Arnold & Porter ordered by Published Date Descending.
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New Developments In DTC Television Advertising: Disclosing Prescription Drug List Prices
In May 2018, amidst mounting public discussion, the Department of Health and Human Services (HHS) released a sweeping document entitled "HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Cost."
United States
19 Sep 2019
What Is News?
The court first ruled that not everything on the internet qualifies as news media.
United States
9 Aug 2019
With Big Third Quarter (And Even Bigger Beginning To Q4), DOJ Fast Approaching Total FCA Recoveries From FY2018
As usual, the Q3 numbers were driven mainly by a handful of large recoveries—mostly from the pharmaceutical industry.
United States
9 Aug 2019
The Trump Administration Drug Importation Action Plan
In the past, such proposals have largely been met with resistance by the FDA.
United States
5 Aug 2019
Update On The Implementation Of The European Medical Devices Regulation And In Vitro Diagnostics Regulation
On May 26, 2017, the new European Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force.
European Union
2 Aug 2019
In Recent "Original Source" Decision, Relator's Pre-2010 "Secondhand" Claims Back-Handed By Third Circuit
A recent Third Circuit decision reaffirmed the high bar a relator must meet to qualify as an "original source" under the pre-2010 version of the False Claims Act's (FCA) public disclosure bar.
United States
12 Jul 2019
New Guidance Under The EU MDR
The guidance does not clarify if the same PRRC can act for multiple manufactures.
European Union
12 Jul 2019
License To Bill: West Virginia Takes Closer Aim On Materiality
Materiality" in the context of False Claims Act actions based on false implied certification becomes better understood with each post-Escobar decision.
United States
11 Jul 2019
Update On The European MDR And IVDR (June 2019)
We set out below an update on the current state of play.
European Union
10 Jul 2019
Localization Barriers To Trade In Medicines And Health Care Products: The Tricky Business Of Balancing Competing Interests
He also highlights the increasingly challenging political and economic environment faced by industries.
5 Jul 2019
EMA Releases Draft Guidelines On Drug-Device Combinations
DDCs are human medicines that include a medical device.
European Union
19 Jun 2019
United States
20 May 2019
Appointment Cancelled? Supreme Court Asked To Consider Constitutionality Of FCA's Qui Tam Provisions Under The Appointments Clause
Could what started with a footnote end with the False Claims Act's qui tam provisions being declared unconstitutional?
United States
20 May 2019
How The New FCA Cooperation Credit Guidelines Fall Short
The thing about a grab bag or the proverbial box of chocolates is that you never know what you are going to get.
United States
14 May 2019
Don't Take It For Granted: Settlements With Grant Recipients Spike As FCA Recoveries Continue Uptick From FY2018
Two recoveries account for nearly half of the total dollars recovered this quarter.
United States
7 May 2019
Pippins Quoted In Natural Products Insider On FDA Regulatory Issues
She also discussed how the recent departure of Commissioner Scott Gottlieb from the FDA will impact the consumer products industry.
United States
23 Apr 2019
Mulryne Quoted In The Pink Sheet On Brexit Ramifications For Pharmaceutical Industry
The article considers how UK-based life sciences companies can prepare for the UK's departure from the EU despite uncertainty surrounding the UK's unconfirmed exit deal.
16 Apr 2019
FTC And Teva Reach Global Settlement Of Reverse-Payment Charges
For years the US Federal Trade Commission (FTC) has been challenging so-called "reverse payment" agreements, where brand and generic pharmaceutical companies settle patent infringement claims
United States
29 Mar 2019
Impact Of UK's Temporary Tariff Regime On Life Sciences
The UK Government published today details of the temporary tariff regime that will apply from 11pm on 29 March 2019 if the UK leaves the European Union (EU) ...
European Union
24 Mar 2019
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