Searching Content indexed under Healthcare by Hogan Lovells ordered by Published Date Descending.
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Guidances Galore: FDA Finalizes Multiple Digital Health Guidance Documents
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's ...
United States
14 Oct 2019
Physicians' Difference Of Opinion Not Enough For FCA Liability
The Eleventh Circuit raised the bar for whistleblowers and the government in False Claims Act cases. Hogan Lovells attorneys say it confirms that a mere difference of opinion between medical
United States
7 Oct 2019
Eleventh Circuit Confirms: Mere Difference Of Opinion Between Physicians Does Not Establish Falsity Under The False Claims Act
More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that "contradiction based on clinical
United States
16 Sep 2019
FDA Issues Updates To Fourth Edition Seafood HACCP Guidance
The U.S. Food and Drug Administration recently released an updated Fourth Edition of its Guidance for Industry entitled, "Fish and Fishery Products Hazards and Control Guidance, Fourth Edition – August 2019".
United States
2 Sep 2019
Lawsuit Seeks To Compel FDA To Implement FSMA's Laboratory Accreditation Provisions
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA).
United States
28 Aug 2019
A Bit More Sunshine: CMS Proposes Collecting Additional Information On Manufacturer Payments Under The Open Payments Program
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS)
United States
20 Aug 2019
Online Sale Of Pharmaceuticals In Russia Remains Prohibited And Lawmakers Are Yet To Pass The Bill Allowing Online Sales
Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence.
Russian Federation
13 Aug 2019
Approval Of Amendments To The General Health Law Concerning Front Labeling Of Food And Non-Alcoholic Beverages
On July 24, 2019, the Health Commission of the Chamber of Deputies approved the draft opinion that amends and adds various provisions to the General Health Law concerning overweight
2 Aug 2019
Medical Foods Workshop: Science, Regulation And Practical Aspects
Xin Tao will serve as a panelist during the "Concepts around Differentiating Medical Foods and FSDU" session on 14 August.
United States
1 Aug 2019
Senate Finance Committee Releases Details Of Drug Pricing Bill
If enacted into law, the bill would have wide-ranging implications and would directly affect, among other stakeholders, drug manufacturers, insurers, hospitals, and physicians.
United States
1 Aug 2019
View From The Horizon: Pricing And Financial Regulation Of Health Products In France
On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products
31 Jul 2019
CMS Radiation Oncology Model Proposed Rule – Summary And Early Insights
Last week, the Centers for Medicare & Medicaid Services (CMS) announced new details of a proposed bundled payment model for radiation oncology services.
United States
25 Jul 2019
CDRH Issues Final Rule On Appeals, Excluding De Novos From 517A
On 2 July 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final rule1 updating the processes for appeal of certain FDA decisions related to medical devices regulated
United States
18 Jul 2019
MDRP And The U.S. Territories: Manufacturer Rebate Obligations, But No Mandatory Coverage, In Case Of A Section 1115 Waiver?
In the ACA Final Rule, the Centers for Medicare & Medicaid Service (CMS) expanded the definition of the terms "States" and "United States.
United States
18 Jul 2019
Fuelling Healthcare Innovation: Poland Creates New Medical Research Agency
In March 2019, the new law creating a Medical Research Agency ("the Agency") entered into force in Poland. This new entity is intended to play a similar role to institutions like the UK's Medical
12 Jul 2019
Balancing Safety And Efficiency: Updating The Regulation On Pharmaceuticals And Medical Devices
It's been five years since both the name and the content of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Act")
12 Jul 2019
Mobile Phones And Exposure To EMF: Stay Tuned For More Information, Soon
In a decision handed down on 15 January 2019, the Regional Administrative Court of Lazio ("TAR Lazio") ordered the Ministry of Environment, the Ministry of Health and the Ministry of Education,
11 Jul 2019
Settlement Reached In Lawsuit To Compel FDA To Implement FSMA Traceability Provisions
The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the
United States
5 Jul 2019
View From The Horizon: Artificial Intelligence And Cannabusiness In London
On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges
27 Jun 2019
U.S. Supreme Court Ruling Expands Scope Of Medicare Notice-And-Comment Requirement
On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive
United States
24 Jun 2019
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