Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Morgan Lewis ordered by Published Date Descending.
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California To Ban Sale And Import Of Cosmetics Tested On Animals - Retail Did You Know?
California has introduced a law that prohibits selling or importing into California any cosmetic product that involved testing on animals.
United States
14 Dec 2018
State Drug Price Transparency Laws Present Reporting Issues For Biopharma
Some states have recently enacted legislation regarding drug price transparency in an attempt to respond to the public and payor concerns regarding prescription drug cost and pricing,
United States
15 Nov 2018
Court Interprets Trade Agreements Clause Applicable To Federal Procurements Above $180,000
The US Court of Federal Claims recently interpreted the Trade Agreements Clause applicable to federal government procurements of more than $180,000 as permitting the purchase of domestic end products...
United States
18 Jul 2018
Final Guidance On IRB Written Procedures Issued
The guidance is intended to assist institutional review boards and institutions in developing written procedures.
United States
24 May 2018
Federal Circuit Holds Vanda's Method Of Treatment Claims Pass Mayo/Alice's Step One
In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13...
United States
18 Apr 2018
FDA Delays EMDR System Adverse Event Codes Update
The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply.
United States
5 Apr 2018
Moratorium On Medical Device Excise Tax Extended For Two Years
With the passage on January 22 of continuing appropriations through February 8 (HR 195), the moratorium on the medical device excise tax has been further extended until January 1, 2020...
United States
26 Jan 2018
What Pharma Companies Need To Know About FDA's New Draft IVD Guidance
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD...
United States
25 Jan 2018
Amgen Moves To Dismiss Genentech's Misrepresentation Claim
Amgen paints a different picture as to the bad actor during the parties' negotiations pursuant to the Biologics Price Competition and Innovation Act.
United States
10 Jan 2018
Federal Circuit OK's Use Of Post-Priority-Date Evidence
The US Court of Appeals for the Federal Circuit issued its opinion on October 5 in Amgen Inc. v. Sanofi, Case No. 2017-1480...
United States
16 Oct 2017
FDA Announces Digital Health Innovation Action Plan To Implement 21st Century Cures Act
Agency also launches voluntary pilot program as first step in developing software pre-certification program.
United States
21 Aug 2017
Humira Patents Invalidated In Inter Partes Reviews
AbbVie's arguments raised in a prior IPR were key to the PTAB's finding of no commercial success.
United States
23 Jun 2017
Proof By Proxy In FCA Suits? District Court Says It Depends
In a February 14, 2017 decision, the Fourth Circuit declined to rule on the question of whether statistical sampling can be used to prove liability and damages in False Claims Act (FCA) lawsuits...
United States
6 Mar 2017
FDA Devices Center Issues Multiple Guidances In The Obama Administration's Final Months
A flurry of regulatory activity preceded the transition in administration on January 20.
United States
27 Feb 2017
New Approach For Biologic And Biosimilar Names
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
United States
1 Feb 2017
FDA Issues Final Guidance On Postmarket Cybersecurity
On December 28, 2016, FDA issued a final guidance titled "Postmarket Management of Cybersecurity in Medical Devices" (Final Guidance).
United States
13 Jan 2017
FDA Issues Final Guidance On "Emerging Signals"
On December 14, 2015, the FDA issued a final guidance titled "Public Notification of Emerging Postmarket Medical Device Signals" (Final Guidance). Under the Final Guidance, the FDA's Center for Devices...
United States
3 Jan 2017
Federal Circuit Reverses PTAB Patent Invalidation Based On Lack Of APA Due Process
Inter partes review (IPR) petitioners must ensure adequate notice of arguments against validity;
United States
21 Dec 2016
21st Century Cures Act And Its Effect On Digital Health
On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it.
United States
15 Dec 2016
21st Century Cures Act And Medical Device Regulatory Pathways
These seven key provisions will affect the premarket requirements for medical devices.
United States
15 Dec 2016
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