Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Steptoe & Johnson LLP
In our 281st episode of The Cyberlaw Podcast, Stewart Baker is joined by David Kris (@DavidKris) and Nick Weaver (@ncweaver) to discuss
Fross Zelnick Lehrman & Zissu, PC
Viridis Pharmaceutical Ltd.'s (Viridis) use of BOSWELAN in connection with clinical trials for a drug to treat multiple sclerosis was held to be insufficient evidence of genuine use to defeat a non-use cancellation action ...
Butler Snow LLP
In 2010, Fed. R. Civ. P. 26 was amended to require full expert reports and other disclosures for retained expert witnesses,
Holland & Knight
The FDA's patient engagement efforts are continuing.
Reed Smith
In our How Not To Create an "Exception" to the Learned Intermediary Rule post two years ago, we criticized a couple of Texas trial court cases for attempting to create a company ...
Hogan Lovells
On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document
Squire Patton Boggs LLP
The appellants filed this patent infringement suit in the Western District of Texas. The district court found improper venue, and transferred the case to Delaware.
Mintz
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act ("Section 3060 Changes Guidance") – Final
Fenwick & West LLP
Industry leaders anticipate that the use of artificial intelligence in medical imaging will have a substantial clinical impact, ushering in an opportunity to significantly improve decision support...
BakerHostetler
FDA Releases Report on Foodborne Illnesses – The FDA posted a report titled "Foodborne illness source attribution estimates for 2017 for Salmonella,...
Ropes & Gray LLP
On September 27, 2019, the U.S. Food and Drug Administration ("FDA") issued a revised draft guidance entitled "Clinical Decision Support Software"
Reed Smith
This post is a follow-up of sorts to our "Stupid Expert Tricks" post. That post dealt with dodgy games that our opponents' experts play.
McDermott Will & Emery
The FDA recently released six guidance documents as part of the agency's continued focus on updating the regulatory stance on software as a medical device and other digital health products
Butler Snow LLP
If you have ever read The Jungle Book, a collection of stories by Rudyard Kipling, Rikki-Tikki-Tavi should sound familiar.
Foley Hoag LLP
On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act ("FCA")
Duane Morris LLP
With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing.
Duane Morris LLP
The FCA creates liability for persons or entities found to have knowingly submitted false claims to the government or having caused others to do so.
Wilson Sonsini Goodrich & Rosati
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019
Hogan Lovells
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 ...
Hogan Lovells
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), ...
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Oblon, McClelland, Maier & Neustadt, L.L.P
Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined
Sheppard Mullin Richter & Hampton
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
Shook, Hardy & Bacon L.L.P.
Plaintiffs' attorneys are spending billions of dollars saturating the airwaves with advertisements that target prescription drugs and medical devices for lawsuits.
Arnold & Porter
Viridis's use of the BOSWELAN mark during the clinical trial was purely internal in nature.
Marshall, Gerstein & Borun LLP
What is synthetic biology? At a fundamental level, synthetic biology is an interdisciplinary area applying engineering principles to biology ...
Reed Smith
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 ...
Duane Morris LLP
With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing.
Reed Smith
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
Debevoise & Plimpton
Following last year's enactment of the Foreign Investment Risk Review Modernization Act ("FIRRMA"), the U.S. Department of Commerce ("DOC")...
Duane Morris LLP
Genetic testing and telemedicine targeting senior citizens and individuals with disabilities have been the subject of growing government scrutiny.
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