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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Hogan Lovells ordered by Published Date Descending.
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1
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
2
Proposed Additions Of Chemical Families To Schedule 1 Of Chemical Weapons Convention And BIS Requests For Comments From Chemical, Biotechnology And Pharmaceutical Companies
On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC).
United States
20 Aug 2019
3
New Draft Guidance On MR Compatibility For Medical Devices
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
United States
15 Aug 2019
4
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
5
Regulation Of Cannabis In Italy: Use In Food And Cosmetics
In Italy the cultivation and the industrial use of hemp has a long tradition and recent changes in law have led to a revival.
Italy
6 Aug 2019
6
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
Mexico
2 Aug 2019
7
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
8
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
9
National Advertising Division Issues Decision On "0 G Added Sugars" Claim For Oatmilk
Oatly, Inc. has chosen to discontinue its "no added sugars" advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD)
Belgium
31 Jul 2019
10
FDA Details Recommendations For Live Case Presentations During Medical Device Clinical Trials In Final Guidance
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials
United States
31 Jul 2019
11
FDA Announces Reinspection And VQIP Fees For Fiscal Year 2020
The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation
United States
31 Jul 2019
12
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
France
31 Jul 2019
13
FDA Finalizes Guidance On How To Determine Whether A Company Meets The "Small Business" Definition Under The FSMA Preventive Controls Regulations
The U.S. Food and Drug Administration (FDA) recently finalized its "Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business' Definition in Parts 117 and 507
United States
26 Jul 2019
14
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
15
New Human Genetic Resources Regulations In China
On 28 May 2019, the People's Republic of China State Council promulgated the People's Republic of China Human Genetic Resources
China
23 Jul 2019
16
FSIS Issues Compliance Guideline On Kit Labeling
Yesterday, FSIS issued its long-awaited guidance on the labeling and packaging of "kit" products. 1/ Although FSIS has long informally applied its "kit policy,"
United States
18 Jul 2019
17
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
18
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
19
FDA Issues Draft Guidance On Reducing Microbial Food Safety Hazards In The Production Of Seed For Sprouting
FDA recently released a Draft Guidance for Industry entitled, "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting" ("Draft Guidance"). The Draft Guidance
Belgium
15 Jul 2019
20
OMB Releases Spring 2019 Unified Agenda Of Regulatory Actions
This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA)
United States
15 Jul 2019
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