Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Hogan Lovells ordered by Published Date Descending.
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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
Final Guidance Provides Additional Clarity To The Humanitarian Device Exemption Program
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
United States
12 Sep 2019
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
Uncertainty Remains: FDA Releases New Benefit-Risk Decision Tree For Medical Device PMAs And De Novos In Concert With Final Uncertainty Guidance
On 30 August 2019 the U.S. Food and Drug Administration issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals.
United States
9 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
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
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
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 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
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
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