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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Ropes & Gray LLP's Health Care Practice ordered by Published Date Descending.
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New International Pharmaceutical Practice Code Tightens Restrictions On Gifts
On January 1, 2019, the revised Code of Practice issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) went into effect.
United States
7 Mar 2019
2
AdvaMed Releases Updated Code Of Ethics
The Advanced Medical Technology Association ("AdvaMed") has updated its Code of Ethics on Interactions with U.S. Health Care Professionals (the "Code").
United States
4 Feb 2019
3
Changes In Federal Regulation Of CBD And Other Hemp Products Will Create New Opportunities For Investment, But Regulatory Challenges Remain
On December 20, 2018, President Trump signed the Agriculture Improvement Act of 2018 (P.L. 115-332), commonly referred to as the "2018 Farm Bill," into law
United States
16 Jan 2019
4
Implications Of Distributor Misconduct For Global Health Care And Life Sciences Companies
Health care and life sciences companies with operations in the United States and abroad face increased liability arising from their common reliance on third-party distributors in international markets.
United States
2 Aug 2018
5
Revisions To Common Rule Delayed Until January 21, 2019
In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, typically referred to as the Common Rule ...
United States
20 Jun 2018
6
Major Effects of Revised Common Rule on Regulation of Clinical Research in New York
On January 19, 2017, the U.S. Department of Health and Human Services (HHS), together with 15 other federal Departments and Agencies, issued a final rule to revise and modernize the federal Policy for the Protection of Human Subjects (the Common Rule), the set of federal regulations governing the conduct of clinical research involving human subjects.
United States
20 Feb 2017
7
The GDPR – Possible Impact On The Life Sciences And Healthcare Sectors
Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016, (the "GDPR") came into force in May 2016 and introduced a number of changes to European data protection law.
United States
10 Feb 2017
8
HHS Finalizes Major Changes To The Common Rule
Many of the provisions of the final rule will take effect in January 2018.
United States
21 Jan 2017
9
21st Century Cures Act – Provisions To Promote Drug Development
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
10
21st Century Cures Act – Provisions Relating To Digital Health
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
11
21st Century Cures Act – Provisions Relating To Development Incentives For Certain Classes Of Drugs
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
14 Dec 2016
12
European Health Care Compliance Challenges (And Solutions)
Future alerts will address these topics in greater detail.
European Union
20 Oct 2016
13
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.
China
30 Sep 2016
14
HHS Grants 30-Day Extension On Comment Period For Common Rule Revisions
Today, the Department of Health and Human Services ("HHS") published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects ("Common Rule") notice of proposed rulemaking ("NPRM") by 30 days to January 6, 2016.
United States
25 Nov 2015
15
HHS Proposes Major Overhaul Of The Common Rule
In 1991, HHS developed a set of regulations, adopted by 15 federal departments and agencies, to create a uniform body of regulations to protect human subjects involved in clinical research.
United States
10 Sep 2015
16
Clinical Trial And Medicare Provider Quality Improvement Provisions In House Committee 21st Century Cures Discussion Draft
On January 27, 2015, the House Energy & Commerce Committee ("Committee") released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative.
United States
20 Feb 2015
17
OIG Issues Special Advisory Bulletin On Pharmaceutical Manufacturer Copayment Coupons
On September 19, 2014, the HHS Office of Inspector General issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons.
United States
24 Sep 2014
18
Key FDA Officials Signal Approach To Review Of Biosimilar Products
In an article published in yesterday's New England Journal of Medicine ("NEJM"), several key officials with the Food and Drug Administration ("FDA") outlined an approach to review and approval of biosimilars in the United States.
United States
17 Aug 2011
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