Search
Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Hogan Lovells ordered by Published Date Descending.
Links to Result pages
 
1 2 3 4 5 6  
>>Next
 
Title
Country
Organisation
Author
Date
1
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
2
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
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On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...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
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
6
FDA Issues Draft Guidance On Providing Regulatory Submissions In Electronic Format
On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices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
7
FDA Announces New Expedited Program For Devices Expected To Significantly Improve The Safety Of Existing Technologies
On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices"
United States
30 Sep 2019
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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
Links to Result pages
 
1 2 3 4 5 6  
>>Next