Searching Content by Ropes & Gray LLP's Government Enforcement/White Collar Crime Practice from Ropes & Gray LLP ordered by Published Date Descending.
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World Bank Group Debars Brazil-Based Odebrecht Subsidiary Amid Allegations Of Fraudulent And Collusive Practices
The World Bank Group ("World Bank") continues to take action against companies that commit fraud in connection with World Bank-financed projects.
United States
12 Feb 2019
FDA Issues Final Guidance Documents Relating To Medical Product Manufacturer Communications
The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.
United States
18 Jun 2018
Sanctions Enforcement – Recent Trends
Last year also saw the implementation of two other important pieces of legislation concerning sanctions enforcement.
12 Mar 2018
Tax Reform: Deductibility Of Government Payments Materially Limited
This exception does not apply to an order or agreement requiring court approval unless the approval was obtained before enactment.
United States
28 Dec 2017
Shanghai Tightens Industry Interactions With HCPs
In August 2017, multiple departments of Shanghai government, led by Shanghai's Health and Family Planning Commission, jointly issued a series of administrative rules to tighten the interactions...
12 Oct 2017
CFIUS Continues To Present An Obstacle To Chinese Acquisitions
On September 13, 2017, President Donald Trump issued an Executive Order blocking investment firm, Canyon Bridge Capital Partners Inc., from acquiring Lattice Semiconductor Corporation.
United States
19 Sep 2017
MedPAC Takes Anti-POD Stance In Report To Congress, Echoing An Increasingly Uniform Consensus
On June 15, 2017, the Medicare Payment Advisory Commission, a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System.
United States
26 Jun 2017
Managing Sanctions And Export Control Risks In The Health Care Industry
Over the past 15 years, pharmaceutical manufacturers, medical device companies, and other participants in the health care industry have been regular targets of FCPA enforcement actions brought by the U.S. government.
United States
15 May 2017
South Korea Fines Prominent Pharmaceutical Manufacturer in Latest Anti-Corruption Enforcement Efforts
In a sign that South Korea is ramping up its anti-corruption enforcement efforts, Korean authorities announced on April 27 that they plan to levy a $48 million fine against Swiss pharmaceutical giant...
3 May 2017
A Judicial Reinterpretation of the Brazilian Constitution's Right to Health Care
In recent years, there has been a spike in right-to-health litigation in Brazil wherein citizens seek court orders mandating that certain medications be dispensed through the public health system (Sistema Único de Saúde—"SUS").
31 Mar 2017
FDA Issues Three Key Documents Relating To Medical Product Manufacturer Communications
These documents represent a final attempt by the outgoing Administration to impact the agency's regulatory approach going forward.
United States
2 Feb 2017
Update On The Anti-Corruption Landscape In Mexico
After an aggressive grassroots campaign, in mid-2016, the Mexican government signaled substantial progress in its fight against corruption when it adopted a new anti-corruption program.
21 Dec 2016
FDA Holds Public Hearing On Manufacturer Communication Of Scientific And Medical Information
This Alert summarizes several key aspects of the hearing and describes its potential significance for regulated industry.
United States
15 Nov 2016
Podcast: FDA Holds Public Hearing On Manufacturer Communication Of Scientific And Medical Information
In this podcast, Doug Hallward-Driemeier moderates a discussion with partner Kellie Combs and senior counsel Alan Bennett about the FDA's open hearings regarding off-label communications.
United States
15 Nov 2016
European Health Care Compliance Challenges (And Solutions)
Future alerts will address these topics in greater detail.
European Union
20 Oct 2016
Donations And Grants In China: Compliance Controls Beyond T&E
Additionally, it may be worthwhile to understand the level of compliance controls employed by the intermediary to assess third-party compliance risks.
30 Sep 2016
FDA Announces Public Hearing On Manufacturer Communications Regarding Off-Label Uses
On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices.
United States
7 Sep 2016
Supreme Court Endorses Implied Certification Theory Under False Claims Act —"At Least In Some Circumstances"
On June 16, 2016, the Supreme Court of the United States issued a unanimous opinion addressing the scope and reach of the False Claims Act ("FCA").
United States
23 Jun 2016
Off-Label Enforcement Developments (Vascular Solutions, Inc. Acquittal and Amarin Settlement)
Two important cases involving the permissible scope of speech regarding off-label marketing recently resolved in ways that should bolster efforts by drug and device manufacturers to secure their First Amendment rights to make truthful, non-misleading statements about potential off-label uses of their products.
United States
11 Mar 2016
Ropes & Gray Advises Pacira Pharmaceuticals In Reaching Landmark Settlement Agreement With FDA
A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA.
United States
17 Dec 2015
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