Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Ropes & Gray LLP ordered by Published Date Descending.
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A Guide To FCA Cooperation Credit For Life Sciences Companies
On May 7, 2019, the U.S. Department of Justice issued guidelines describing when and under what circumstances it will award cooperation credit in False Claims Act matters.
United States
9 Jul 2019
Podcast: Non-Binding Guidance: Examining FDA's Enforcement Authority Over Stem Cell Clinics And Compounders
The third installment of Ropes & Gray's podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas.
United States
4 Jul 2019
China's State Council Publishes New Regulations On The Management Of Human Genetic Resources
China's State Council, the country's top administrative authority, released a new Regulation of Human Genetic Resources1 (the "Regulation") on May 28, 2019, to replace the tentative rules issued
26 Jun 2019
New FDA Draft Guidance On Voluntary Recalls Asks: Are You Prepared?
On April 24, 2019, the Food and Drug Administration ("FDA") released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,"
United States
21 May 2019
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb's Unfinished Business
Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.
United States
8 May 2019
Senators Ask HHS To Step Up Scrutiny Of Pods Under Sunshine Act
On March 19, 2019, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) of the Senate Finance Committee ("SFC") wrote a letter (the "POD Letter") to the HHS Office of Inspector General ("OIG")
United States
3 May 2019
Podcast: Non-Binding Guidance: FDA's Regulation Of Products Containing CBD
Ropes & Gray's new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry.
United States
2 Apr 2019
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
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
China Aims To Introduce Routine Drug And Device Overseas Inspections
China's drug and device regulator recently announced a set of rules signaling increased scrutiny of foreign drug and device companies.
18 Jan 2019
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
IRS Considers Giving More Ventures Access To Tax-Free Spinoffs
Significantly, pending completion of its study, the IRS will entertain private letter ruling requests on the issues described in the announcement.
United States
3 Oct 2018
Distributors Expose Health, Life Sci Cos. To FCPA Risks
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
29 Aug 2018
The Impact Of Scientific Data Administrative Measures On Foreign Companies In China
On March 17, 2018, the Chinese State Council passed the Scientific Data Administrative Measures (the "Measures") to standardize the management of scientific data at a national level.
17 Aug 2018
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
China's New Medical Device Regulations Bring Big Changes
The current MDR requires medtech companies to either conduct clinical studies in China or submit clinical evaluation reports illustrating equivalence to previously approved products
31 Jul 2018
Podcast: IP Life Sciences Landscape: Aiding Orange And Purple Book Patent Owners In Developing PTAB Survival Skills
In the last three years, there has been an uptick in the use of inter partes review proceedings by the generic-side of the bio/pharma industry.
United States
24 Jul 2018
China's MOJ Solicits Comments On Amendment To Medical Device Regulations
The PRC Ministry of Justice recently published a comprehensive draft amendment ("Draft Amendment") outlining the proposed revisions to the current Medical Device Regulations.
United States
3 Jul 2018
FDA Clarifies Communication Rules For Medical Product Companies
On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling.
United States
25 Jun 2018
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
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