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Searching Content indexed under Food and Drugs Law by Hogan Lovells ordered by Published Date Descending.
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1
FSMA Update: FDA Publishes List Of Required Foreign Supplier Verification Program Records
The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP)
United States
21 Oct 2019
2
California Chamber Of Commerce Challenges The Proposition 65 Acrylamide Warning for Foods
We would like to bring to your attention a lawsuit that was filed yesterday by the California Chamber of Commerce challenging the legality of Proposition 65 warnings on foods that contain acrylamide
United States
21 Oct 2019
3
Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...
United States
11 Oct 2019
4
Pharma Patent Litigation In Russia: Latest Trends
In Russia 2018 and 2019 have been interesting years for patentlitigation. A number of revolutionary rulings were made in favor...
Russian Federation
10 Oct 2019
5
FDA Issues Draft Guidance On Providing Regulatory Submissions In Electronic Format
On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices
United States
4 Oct 2019
6
FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0
The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB)
United States
26 Sep 2019
7
FDA Announces Public Meeting And Docket For Comments On "A New Era Of Smarter Food Safety" To Facilitate FSMA Implementation
The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding "A New Era of Smarter Food Safety."
United States
25 Sep 2019
8
FDA Releases Four Final Guidances On The 510(k) Program; Special 510(k) Guidance Confirms New Approach To Eligibility And Broader Potential For IVDs
On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program:
United States
24 Sep 2019
9
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
10
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
11
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
12
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
13
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
UK
28 Aug 2019
14
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
15
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
16
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
17
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
18
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
19
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
20
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
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