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Searching Content indexed under Food and Drugs Law by Ropes & Gray LLP's Health Care Practice ordered by Published Date Descending.
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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
2
Another Step Toward Harmonization: FDA Issues Proposed Rule To Waive Informed Consent Requirements In Minimal-Risk Studies
On November 15, 2018, the U.S. FDA published a proposed rule1 that would allow IRBs to waive or alter informed consent when a clinical investigation poses no more than minimal risk to, and includes appropriate safeguards...
United States
30 Nov 2018
3
HHS Proposes January 1, 2019 Rollout Of The 340B Drug Pricing Program's Civil Monetary Penalties And Clarified Drug Ceiling Price Calculation
On November 2, 2018, the Health Resources and Services Administration of the United States Department of Health and Human Services
United States
29 Nov 2018
4
CMS Outpatient Payment, MA Plan Design, And 340B Rules: Cost-Cutting Trends
These final rules, released for prepublication display on November 1 and 2, reinforce a developing trend away from delivery of care in traditional inpatient care settings.
United States
29 Nov 2018
5
California Enacts Bill On Drug Pricing Transparency
California is one of several states to have recently enacted drug pricing laws in response to growing debate over prescription drug costs.
United States
17 Oct 2017
6
FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research
The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB's waiving or altering the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections.
United States
26 Jul 2017
7
Drug And Device Makers Suggest Anti-Kickback Safe Harbor Clarifications To Encourage Value-Based Health Care Arrangements
Drug and device makers, and related trade groups, have responded with proposals to provide additional clarity around value-based health care.
United States
20 Mar 2017
8
President Trump Announces Health Care Priorities: Repeal/Replace of Obamacare; Tort Reform on Agenda
February 27, 2017, President Trump gave his first address to a joint session of Congress, outlining key points of his administration's agenda
United States
4 Mar 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
FDA Examining Role Of Hospitals In Medical Device Surveillance
On October 25, 2016, FDA announced an upcoming public workshop entitled, "The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance."
United States
29 Oct 2016
13
House Passes 21st Century Cures Act: What Does It Mean For Clinical Research?
On July 10, 2015, the U.S. House of Representative passed H.R. 6, the 21st Century Cures Act, with strong bipartisan support in a vote of 344-77.
United States
24 Jul 2015
14
Medicare, Medicaid, And Enforcement Implications Of The 21st Century Cures Act Recently Passed By The House
The bill aims to bring new drugs to market faster by encouraging medical innovation, and grants additional funding to the NIH and Food and Drug Administration.
United States
24 Jul 2015
15
21st Century Cures Act – Provisions Relating To Digital Health: Interoperability And Information Blocking
On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the "bill") by a vote of 344-77.
United States
24 Jul 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
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