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China Proposes Major Changes To Pharmaceutical Regulations
On April 20, 2019, the Chinese government submitted a second draft of the Drug Administration Law of the People's Republic of China to the Standing Committee of the NPC for deliberation.
30 May 2019
A Closer Look At CMS' Drug Price Disclosure Proposal
One important difference between the standards is how strong the government's interest must be in order to justify the regulation.
United States
29 Oct 2018
CMS Issues Proposed Rule To Require Disclosure Of List Price In Direct-To-Consumer Advertising For Prescription Drugs And Biological Products
Allow the Department of Health & Human Services to maintain a public list of drugs and biological products advertised in violation of the rule.
United States
24 Oct 2018
Ropes & Gray's Investment Management Update: August – September 2017
The following summarizes recent legal developments of note affecting the mutual fund/investment management industry:
United States
12 Oct 2017
First Circuit Affirms Dismissal Of FCA Off-Label Marketing Case For Failure To Meet 9(b) Particularity Requirement
In Lawton v. Takeda Pharmaceutical Co. et al., 842 F.3d 125 (1st Cir. 2016), the First Circuit affirmed the lower court's dismissal of a FCA suit alleging a drug maker fraudulently marketed a product for off-label uses.
United States
2 Feb 2017
China Announces A Detailed Pilot Plan For The Marketing Authorization Holder System For Drugs In Selected Regions
China's State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System ("MAH") for drugs in 10 provinces in China.
15 Jun 2016
FTC's Proposed Settlement With Dental Practice Software Provider Marks Latest Data Security Action Against A Product Supplier
On January 5, the FTC reached an agreement with Henry Schein Practice Solutions, Inc. to settle allegations that HSPS misrepresented that its dental practice software provided industry-standard encryption for personal information.
United States
8 Feb 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
Amarin Court Holds Truthful Off-Label Speech Entitled To First Amendment Protection
On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA...
United States
13 Aug 2015
China Tightens Advertising Rules For Life Sciences Companies
This year China's Advertising Law will see its first amendment in two decades.
20 Jul 2015
Supreme Court Unanimously Reverses Ninth Circuit's Decision In "POM Wonderful v. Coca-Cola"
On June 12, 2014, the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. ruled that a competitor may bring a Lanham Act false advertising claim.
United States
18 Jun 2014
Supreme Court Sets New Test In Lexmark For Whether A Party Has Standing To Bring A False Advertising Claim Under The Lanham Act
On March 25, 2014, the Supreme Court in Lexmark International, Inc. v. Static Control Components, Inc., No. 12-873 (Mar. 25, 2014), ruled that a two-part inquiry pairing the zone-of-interests test and a proximate-cause requirement applies when determining standing for false advertising claims under the Lanham Act, 15 U.S.C. § 1152(a).
United States
28 Mar 2014
FTC Updates Social Media & Online Advertising Guidelines - Disavowing Settled Practices And Imposing Tighter Disclosure Requirements For Digital Advertising
This change is potentially significant, and the new .com Disclosures guidance should be carefully understood by those participating in digital advertising.
United States
25 Mar 2013
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