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Searching Content from United States indexed under Food, Drugs, Healthcare, Life Sciences ordered by Published Date Descending.
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1
Your Part-Time Employees May Be Eligible For Your Company's 401(K) Plan
Although part-time employees are not likely eligible for a company's group health plan because they work fewer than the 25 or 30 hours per week ...
United States
22 Jun 2018
2
ML Strategies Health Care Preview – June 18th
Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis.
United States
22 Jun 2018
3
FDA Guidance On HECI And Communications To Payors Of Unapproved Products And Uses
On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers" (Guidance).
United States
22 Jun 2018
4
The Hobson's Choice Of The Hatch-Waxman Integrity Act
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance ...
United States
22 Jun 2018
5
Health Insurers Take Hit From Appeals Court Ruling On ACA's Risk Corridor Program
A three-judge panel of the U.S. Circuit Court of Appeals for the Federal Circuit on June 14, 2018, reversed the ruling of a U.S. Court of Federal Claims judge against the U.S. Department of Health and Human Services ...
United States
22 Jun 2018
6
Health Care Policy Newsletter - 19 June 2018
Foley & Lardner LLP's ("Foley") Bipartisan Public Policy Team is pleased to share our "Public Policy Weekly* Health Care Newsletter" in which we compile the latest Health care policy news and legislation. *Please note that we publish this newsletter only when Congress is in session.
United States
22 Jun 2018
7
The Hobson's Choice Of The Hatch-Waxman Integrity Act
Similar requirements also would pertain to Paragraph VIII carve-out certifications.
United States
22 Jun 2018
8
Capitol Hill Healthcare Update - June 2018
The House last week approved 38 bills that lawmakers hope will stem the opioid epidemic, and it scheduled votes this week on at least a dozen more
United States
22 Jun 2018
9
Deeming Regulations Litigation Update – Cigar Industry Plaintiffs Seek Stay Of Health Warning Requirements Pending Appeal
The United States Food and Drug Administration recently obtained summary judgment on several cigar industry claims challenging the FDA's Deeming Regulations.
United States
22 Jun 2018
10
USPTO Memo Addresses Federal Circuit Authority On Patent Eligibility Of Some Treatment Methods
In Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals, Ltd., Nos. 2016-2707, 2016-2708 (Fed. Cir. April 13, 2018), the court held that claims to methods of treatment were patent eligible.
United States
22 Jun 2018
11
Most Claims Either Expressly Or Impliedly Preempted In Breast Implant Decision Out Of The Northern District Of Illinois
Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today's case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.
United States
22 Jun 2018
12
FDA Guidance On HCEI And Communications To Payors Of Unapproved Products And Uses
On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees ...
United States
21 Jun 2018
13
HIPAA Authorization For Research: HHS Issues Interim Guidance On Authorization Sufficiency
In the final days of his presidency, Barack Obama signed the 21st Century Cures Act, a sweeping medical innovation bill intended to boost funding for medical research, simplify the approval process...
United States
21 Jun 2018
14
Healthy Dose Podcast: Unlikely Mergers, Acquisitions And Strategic Affiliations In Health Care (Video)
This is the first episode of what will be a bi-monthly podcast during which I will discuss trends and current events in the health care industry.
United States
21 Jun 2018
15
The EU Pharma Incentives Review - Two Studies And A Legislative Proposal Released
On May 28 and 29, 2018, the Commission published two studies aimed at examining the economic and legal impacts of the EU's regime on SPCs in particular, as well as on pharmaceutical incentives and rewards in general.
European Union
20 Jun 2018
16
Following Repeal Of The Individual Mandate, Twenty States Challenge The Affordable Care Act
On February 26, 2018, twenty states (the "Plaintiffs") jointly filed a lawsuit[1] in the U.S. District Court for the Northern District of Texas requesting that the court strike down ...
United States
20 Jun 2018
17
OCR Announces Intention To Move Forward With Development Of Methodology To Distribute Enforcement Funds To Victims Of HIPAA Violations
The Office for Civil Rights (OCR) updated its agenda, outlining proposed and final rules as well as pre-rule document releases for 2018.
United States
20 Jun 2018
18
Seventh Circuit Upholds FDA's Use Of FOIA Exemptions To Refuse Disclosures To Plaintiff
On this date 46 years ago, President Nixon and his aides had a conversation about the Watergate break-in and cover-up.
United States
20 Jun 2018
19
Anacor Pharmaceuticals, Inc. V. Iancu
On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621 ...
United States
20 Jun 2018
20
San Francisco Ordinance Requires Cannabis Business Permit Applicants To Enter Into "Labor Peace Agreements"
Earlier this month, San Francisco's Public Safety & Neighborhood Services Committee unanimously approved an ordinance that requires certain cannabis business permit applicants to agree to enter into a collective bargaining agreement (a "Labor Peace Agreement") with a "Bona Fide Labor Organization" as a condition of receiving a cannabis business permit.
United States
20 Jun 2018
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