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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Foley Hoag LLP ordered by Published Date Descending.
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1
Modernization Of The 510(K) Pathway To Market Medical Devices
Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices.
United States
5 Dec 2018
2
But No One Goes To Jail For Insider Trading, Right? Wrong
Schultz "Jason" Chan, former director of biostatistics at Akebia Therapeutics, Inc. (Nasdaq: AKBA), was sentenced to three years in prison following his conviction for insider trading.
United States
14 Nov 2018
3
Proposed Rule Would Require List Price Disclosure On Consumer Prescription Drug Ads
Check out our recent Alert on the Centers for Medicare and Medicaid Services proposed new rule, which would require prescription drug companies to disclose list prices of most drugs in all direct-to-consumer advertising.
United States
23 Oct 2018
4
Update To The Federal Physician Payments Sunshine Act
On October 3, 2018, the U.S. Senate passed the final version of H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery ...
United States
9 Oct 2018
5
Public Comments To The Proposed National Bioengineered Food Standard
The USDA's Agricultural Marketing Service recently accepted public comments on its Proposed Rule for the labeling of bioengineered foods,
United States
4 Sep 2018
6
Enforcing Federal Cannabis Laws: Summer 2018 Update
With July 1st in the rear-view mirror and provisional licenses spreading throughout the Commonwealth, we thought now would be a good time ...
United States
2 Sep 2018
7
Watch: The New EU General Data Protection Regulation (Video)
Attorneys Colin Zick, Catherine Muyl and Marion Cavalier recently presented a webinar for MichBio U on what the EU's General Data Protection Regulation means for U.S.
United States
20 Apr 2018
8
Product Liability Update: April 2018
Foley Hoag's Product Liability Update is a quarterly update concerning developments in product liability and related law of interest to product manufacturers and sellers.
United States
13 Apr 2018
9
General Data Protection Regulation: What It Means For Us Healthcare/Life Science Companies
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation ("the GDPR") will apply in all Member States of the European Union ("EU") and will replace...
United States
4 Sep 2017
10
General Data Protection Regulation: What It Means For Us Healthcare/Life Science Companies (Part Three)
This is the third post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses.
United States
4 Sep 2017
11
General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)
This is the first post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses.
Worldwide
31 Aug 2017
12
Limiting Extraterritorial Reach Of U.S. Patents: "Substantial" Means More Than One
Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad.
United States
10 Mar 2017
13
Can Kyle Bass Appeal His IPR Loss? Not If Consumer Watchdog Is On The Prowl
So Kyle Bass and his Coalition for Affordable Drugs have been handed a defeat in their first PTAB final written decision. The merits of the case aside, the biggest question in my mind is: can the Coalition appeal?
United States
17 Oct 2016
14
Massachusetts Superior Court Rejects "Innovator Liability" Failure-to-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty To Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant's Labeling But Defendant Did Not
In Rafferty v. Merck & Co., 2016 Mass. Super. LEXIS 48 (Mass. Super. Ct. May 23, 2016), plaintiff sued his prescribing physician and a pharmaceutical manufacturer for injuries...
United States
5 Sep 2016
15
Summary Of The "340B Drug Pricing Administrative Dispute Resolution" Proposed Rule
On August 12, 2016, the Health Resources and Services Administration (HRSA) published a proposed rule entitled "340B Drug Pricing Program; Administrative Dispute Resolution".
United States
24 Aug 2016
16
Federal Circuit Offers Path Through Section 101 Thicket For Biotech Method Patents
Chief Judge Proust, joined by Judges Moore and Stoll, reversed the district court and, in doing so, shed some light on the Supreme Court's two-step subject-matter eligibility test as applied to inventions in the life sciences field.
United States
13 Jul 2016
17
One Patent Law, Two Economic Sectors
Claire Laporte has written a thoughtful article on whether a single patent system can satisfy the competing and perhaps inconsistent demands of life science and high-tech innovation.
United States
31 Mar 2016
18
RICO Indictment Of NECC Executives For Acts Of Second-Degree Murder
In December 2014, the United States Attorney for the District of Massachusetts obtained a sweeping indictment that charges business executives of the New England Compounding Center ("NECC") with 25 acts of second-degree murder as predicate offenses under the Racketeer Influenced and Corrupt Organizations ("RICO") Act.
United States
3 Feb 2015
19
FDA Issues Draft Guidance On General Wellness Products
On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled "General Wellness: Policy for Low Risk Devices."
United States
2 Feb 2015
20
Supreme Court Calls For Greater Deference To District Court Claim Construction
The dispute in Teva focused on the meaning of the claim term "molecular weight."
United States
2 Feb 2015
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