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Searching Content from United States indexed under Life Sciences, Biotechnology & Nanotechnology ordered by Published Date Descending.
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1
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
2
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On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...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
3
Department Of Justice Announces National Enforcement Sweep Of Genetic Testing Laboratories And Telemedicine Providers
Genetic testing and telemedicine targeting senior citizens and individuals with disabilities have been the subject of growing government scrutiny.
United States
11 Oct 2019
4
Life Sciences Investors Beware: Private Equity Firm Settles Federal False Claims Act Suit Regarding Compounding Pharmacy It Managed
On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act ("FCA")
United States
11 Oct 2019
5
Guest Post – Summary Judgment For Defendant On All Counts In Absence Of A Product Defect
Today's guest post is by Reed Smith‘s Jenn Eppensteiner. In it she discusses a recurring theme on the Blog – claimed product "defects" arising from nothing more than the failure of an implanted ...
United States
11 Oct 2019
6
ND Illinois Knocks Out Helmet Concussion Class Actions
The defense has done a good job of preventing class certification of drug and device mass torts. Individual issues of usage, causation, reliance, injury, etc. predominate over alleged common issues.
United States
10 Oct 2019
7
Shook Contributes Chambers Article On Pharma Advertising
Shook Partners Hildy Sastre and Jennise Stubbs, along with Of Counsel Sonali Gunawardhana, have co-authored the USA section of Chambers and Partners'
United States
10 Oct 2019
8
Life Sciences Quarterly (Q3 2019): SEC Enforcement And Class Actions Regarding FDA Communications (Video)
In this recap of our September presentation, which includes video and an accompanying transcript, panelists – life sciences regulatory & compliance partner Kellie Combs,...
United States
10 Oct 2019
9
FDA and Pharmacy Weekly Digest - October 1
Acting FDA Commissioner Discusses Food Safety Modernization Act (FSMA) Progress – Acting Commissioner Sharpless announced the Food ...
United States
9 Oct 2019
10
Pharmaceutical Companies: Beware Of Revocation Of EU Trade Marks For Lack Of ‘Genuine Use' During Clinical Trials
Viridis's use of the BOSWELAN mark during the clinical trial was purely internal in nature.
European Union
9 Oct 2019
11
New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
United States
8 Oct 2019
12
Kaufman And Peterson Focus On Drug And Medical Device MDLs For DRI
Shook Partner Chris Kaufman and Associate Torrey Peterson have co-authored an article for DRI's For the Defense on "Exposing Meritless Claims in Drug and Medical Device Product Liability MDLs."
United States
8 Oct 2019
13
Stupid Expert Tricks
Recently, Bexis was contacted by a reporter who had read the blog's post on ghostwriting. Bexis explained that people at the top of any profession
United States
8 Oct 2019
14
Administration Again Attempts To Lower Drug Prices
In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens.
United States
7 Oct 2019
15
Q3 Government Settlements Round-Up: Life Sciences
Health regulatory news and issues.
United States
4 Oct 2019
16
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
17
"Fully Informing" The FDA
One of the more peculiar things about Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019) ("Albrecht"), ...
United States
3 Oct 2019
18
Life Sciences Patent Network North America 2019
HGF Partner Iain Armstrong will be attending and speaking at LSPN North America 2019 on 16th October. The session will cover ‘CAR–T and other immunotherapies'
United States
1 Oct 2019
19
Court Chooses New Hampshire Product Liability Law: Not-So-Granite Principles
Yesterday was National Punctuation Day; it is a good time to administer a semi-colonic to turgid prose. Today we apply an exclamation mark to our unhappiness with judges whose choice of law
United States
1 Oct 2019
20
FDA And Pharmacy Weekly Digest - September 24
The FDA will hold a public meeting "to give interested persons an opportunity to discuss FDA's effort to modernize food standards of identity and provide information about changes
United States
1 Oct 2019
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