Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Ropes & Gray LLP's Government Enforcement/White Collar Crime Practice ordered by Published Date Descending.
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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
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
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
Second Circuit Holds First Amendment Bars Conviction Based Solely On Off-Label Promotion Of FDA-Approved Drug
In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug.
United States
4 Dec 2012
D.C. Circuit Holds That Former Purdue Pharma Executives Who Pleaded Guilty To Misdemeanor Misbranding May Be Excluded From Participation In Federal Health Care Programs
On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs three former Purdue Pharma executives who pleaded guilty to misdemeanor misbranding of Oxycontin.
United States
8 Aug 2012
Sorrell v. IMS Health Inc. — Supreme Court Strikes Down Law Restricting Pharmaceutical Manufacturers’ Speech
On Thursday, the Supreme Court issued its decision in Sorrell v. IMS Health Inc., a case testing the constitutional limits of governmental restrictions on the speech of pharmaceutical manufacturers. By a vote of 6-3, the Court held that the law at issue — a Vermont statute that prohibits pharmaceutical manufacturers from obtaining or using "prescriber-identifiable information" collected from pharmacists for the purposes of "marketing or promoting a prescription drug" — is a "speaker- and content
United States
30 Jun 2011
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