Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by McDermott Will & Emery ordered by Published Date Descending.
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Is Your Software A Medical Device? FDA Issues Six Digital Health Guidance Documents
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
United States
16 Oct 2019
To Market, To Market: FDA's Digital Health Precertification Program
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive
United States
24 Sep 2019
Reviewing Key Principles From FDA's Artificial Intelligence White Paper
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning
United States
29 Aug 2019
FDA's Breakthrough Device Program: Opportunities And Challenges For Device Developers
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program
United States
26 Jul 2019
Digital Health In The UK: The New Regulatory Environment Under The Medical Device Regulation
Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years.
16 Jul 2019
Health Care Data Compliance In China: 4 Key Questions And Compliance Steps For Multinationals
This post was guest authored by lawyers from MWE China Law Offices, McDermott Will & Emery's strategic alliance in Shanghai.
United States
2 Jul 2019
The Gene Editing Is Out Of The Bottle: No Interference-In-Fact Between Claimed Inventions
The PTAB determined, and the Federal Circuit agreed, that both claimed inventions were separately patentable and did not interfere with each other.
United States
9 Nov 2018
CJEU Issues Landmark Decision On Patent Term Extensions For Medicinal Products
The UK High Court asked the CJEU what the criteria were for deciding whether a product is protected by a basic patent pursuant to Article 3(a) of Regulation No. 469/2009.
European Union
5 Sep 2018
Second Circuit's Mandate Rule Limits New Causation Theories On Remand
On remand, indirect purchasers of the drug ACTOS sought to amend their antitrust complaint to modify their causal theory of harm. The district court denied plaintiffs' first set of amendments...
United States
24 Jul 2018
Throwing Metaphorical Darts: When Is Obvious To Try Not So Obvious?
Addressing whether a patented claim for a formulation was obvious to try, the district court on a motion for summary judgment held that the claim was nonobvious where several prior art...
United States
24 Jul 2018
USDA Publishes Proposed GMO Labeling Regulations
The Agricultural Marketing Service of the US Department of Agriculture (USDA) recently published a proposed rule containing regulations to implement the National Bioengineered Food Disclosure Standard mandated ...
United States
15 May 2018
Should I Convert My Entity? (Video)
Dan Zucker and Alexander Lee discuss the pros and cons of converting your entity from an S corp to a C corp.
United States
8 May 2018
The Law Of Digital Health Book Now Available
We're excited to announce the release of The Law of Digital Health, now available for pre-order through the American Health Lawyers Association.
United States
20 Mar 2018
The Latest: Divestitures Of Complex Pipeline Pharmaceutical Products Off The Table At The FTC
•Bruce Hoffman, acting director of the Bureau of Competition at the Federal Trade Commission (FTC), announced that the FTC will no longer accept divestitures ...
United States
12 Feb 2018
FDA 2017 Year In Review
The US Food and Drug Administration's (FDA's) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration.
United States
22 Jan 2018
McDermott's Reverse Engineered Podcast | Five Hot FDA Issues For Life Science Companies (Video)
Health-related technology is growing at an accelerating rate, as is its demand.
United States
5 Dec 2017
Court Construes "Hydrate" To Require Crystalline Form Following Battle Of The Experts
Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA)...
United States
23 Aug 2017
Wrong Inventor Defense Fails In Pharmaceutical Litigation
Mylan argued that because the direction to perform the study came from the FDA, the invention was either derived from the FDA under § 102(f) or obvious.
United States
9 Mar 2017
FDA: Streamlining Regulations For Clinical Research
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
United States
10 Feb 2017
End Of Year Attention To Health IT And Digital Health Tools In 21st Century Cures
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle...
United States
20 Dec 2016
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