Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Akin Gump Strauss Hauer & Feld LLP ordered by Published Date Descending.
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Podcast: DOJ's New Guidance On Evaluating Compliance Programs: What You Need To Know
In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department's recent guidance on evaluation of corporate compliance programs.
United States
20 Sep 2019
CMS Issues Proposed Revisions To Open Payments/Sunshine Act Reporting Requirements
On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program("Open Payments")
United States
7 Aug 2019
Podcast: CBD, THC, FDA – What You Need To Know About Cannabis And Its Regulation
In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD.
United States
25 Jul 2019
Checking In On FDA's Enforcement Discretion Policy For Laboratory Developed Tests
As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs),
United States
28 May 2019
CMS Proposes Several Changes To Reimbursement For Transformative Medical Technologies
Currently, CMS bases new technology add-on payments on the cost to the hospital for the new medical technology.
United States
15 May 2019
Life Sciences Due Diligence: A Reference Guide For Your Life Sciences Corporate Transactions
These two discrete matters may not signal a new government enforcement strategy to hold private equity and venture capital investors liable under the False Claims Act,
United States
14 May 2019
FDA's AI White Paper: To Be Or Not To Be, That Is The Question
On April 2, the U.S. Food and Drug Administration published a long-awaited exploratory white paper proposing a framework for regulating artificial intelligence/machine learning -based software as a medical device.
United States
26 Apr 2019
AdvaMed Releases Updated Code Of Ethics On Interactions With Health Care Professionals
Revisions to the Code go into effect on January 1, 2020, giving companies nearly a year to review their compliance policies, training ...
United States
24 Jan 2019
Federal Circuit Partially Clarifies Obviousness-Type Double Patenting Law In Two Opinions Released The Same Day
The Court of Appeals for the Federal Circuit issued two opinions on December 7 that address two unsettled questions relating to obviousness-type double patenting (OTDP).
United States
17 Dec 2018
9th Circuit Makes Mandatory Escobar's Implied False Certification Test, But Fails To Faithfully Follow Escobar's Directives
A three-judge panel of the 9th Circuit ruled that False Claims Act (FCA) plaintiffs must satisfy the two-pronged test for implied false certification claims set out in Universal Health Services, Inc. v. United States ex rel. Escobar.
United States
12 Sep 2018
Senate Passes Long-Awaited FDA User Fee Package
President Trump is expected to sign FDARA into law.
United States
9 Aug 2017
Dumping Medicine: Make Sure Pharmaceutical Wastes Aren't Left Behind By Regulatory Reform
Pharmaceutical waste management is a critical issue for hospitals and health care facilities.
United States
12 May 2017
What's New In Washington: 10 Things You Need To Know - March 31 Edition
As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal...
United States
3 Apr 2017
Court Denies Preliminary Injunction In Light Of Pending IPR Of Similar Patent Claims
A district court judge denied a plaintiff's motion to preliminarily enjoin a defendant from selling saliva collection kits for DNA testing.
United States
6 Jan 2017
Key Implications Of The 21st Century Cures Act For Medical Devices
This week, the U.S. Senate passed the comprehensive legislative package referred to as the 21st Century Cures Act.
United States
15 Dec 2016
What Must The Government Prove To Establish That A Defendant Recklessly Interpreted A Statute Or Regulation In Violation Of The False Claims Act?
Any company conducting business with the government must master a wide array of rules and regulations.
United States
26 Feb 2016
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