Searching Content indexed under Food and Drugs Law by Hogan Lovells ordered by Published Date Descending.
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De Novo Requests: FDA Releases Updated RTA Checklist
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests.
United States
11 Sep 2019
FDA Announces Public Meeting On Modernizing Food Standards Of Identity
The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address "Horizontal Approaches to Food Standards
United States
6 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
Soft Drinks Industry Levy ("SDIL") – How We Can Help You
The policy behind SDIL is to reduce childhood obesity by encouraging producers to change the recipes and lower the sugar content of the drinks. The Government estimates that over 50% of
28 Aug 2019
FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA
United States
23 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
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.
6 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
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)
31 Jul 2019
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
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
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
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
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
15 Jul 2019
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
FDA Releases Strategy For The Safety Of Imported Food
The U.S. Food and Drug Administration (FDA) recently released the "FDA Strategy for the Safety of Imported Food" (the "Strategy"), which outlines the agency's approach to ensuring the safety
United States
12 Jul 2019
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