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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Sheppard Mullin Richter & Hampton ordered by Published Date Descending.
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1
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
2
FDA's New Safety And Performance Based Pathway For Medical Devices Reflects A More Modern Approach To Finding Substantial Equivalence
On September 19, 2019, FDA issued a guidance document, "Safety and Performance Based Pathway," describing an optional pathway for medical devices ...
United States
26 Sep 2019
3
Medical Devices – Artificial Intelligence And Reactions To FDA's Proposed Oversight
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...
United States
9 Jul 2019
4
Medical Devices – Artificial Intelligence And Reactions To FDA's Proposed Oversight
In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD)
United States
5 Jul 2019
5
Yes, UCANN!
Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911
United States
15 May 2019
6
Federal Circuit Weighs In On Patent Subject-Matter Eligibility Of Dietary Supplements
The Federal Circuit weighed in on patent subject matter eligibility again last week, finding certain amino-acid containing dietary supplements, and related methods of use, to be patent eligible.
United States
2 Apr 2019
7
HIMSS19 Brings Together Though Leaders On IOT And Telehealth
In our February 13, 2019 blog post, "HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology," we reported on the buzz that emerged ...
United States
27 Feb 2019
8
Comment Deadline Extended: Export Controls On Emerging Technologies
Emerging technology sectors are being reviewed now for new export controls that could take effect in 2019 (list below).
United States
13 Dec 2018
9
Proposed New FDA Labeling Rules Would Result In Increased Generic Drug Product Liability Claims
FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not.
United States
21 Oct 2016
10
En Banc: Federal Circuit Provides Guidance On Application Of On-Sale Bar To Contract Manufacturers
Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a "commercial sale" of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).
United States
19 Jul 2016
11
New EU Rules For Medical Devices
After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation.
European Union
19 Jul 2016
12
PTO Cancer Immunotherapy Fast Track
In response to President Obama's National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the "Cancer Immunotherapy Pilot Program."
United States
12 Jul 2016
13
HHS Recognizes Changing Environment Of Research
The Department of Health and Human Services (HHS) and other Federal Departments and Agencies closed the comment period for the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking...
United States
1 Feb 2016
14
HHS Recognizes Changing Environment of Research: Still Time to Comment
The NPRM proposes to apply The Common Rule to all studies, regardless of funding source, conducted by a U.S. institution that receives federal funding for human subjects research.
United States
20 Dec 2015
15
Mobile Health Apps Are In A Boom Phase – Why Is It So Hard For Pharmaceutical Companies To Find Users?
Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma) companies.
United States
7 Nov 2014
16
FTC v. Actavis On Remand: A New Chapter
District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine.
United States
30 May 2014
17
Proposed Modifications To EHR Incentive Programs
Last year, HHS revised policies and definitions surrounding what constitutes certified EHR technology from the 2011 Edition criteria to the 2014 Edition criteria.
United States
29 May 2014
18
Changes Of The Amended Regulations On Supervision And Administration Of Medical Devices
The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council, effective June 1st, 2014.
China
23 Apr 2014
19
FTC Targets Reporting Of Licensing Of Pharmaceutical Patents With Special Rules For Premerger Notification: What You Need To Know
The FTC adopted special rules for determining whether "exclusive" licenses of pharmaceutical patents must be reported as asset transfers/acquisitions.
United States
24 Mar 2014
20
Ninth Circuit Once Again Affirms That Malicious Actions To Destroy A Competitor Do Not State An Antitrust Claim Unless Accompanied By Injury To Competition
The Ninth Circuit Court of Appeals affirmed the lower court’s grant of summary judgment dismissing DAW Industries’ claims.
United States
10 Mar 2014
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