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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
NDA/ANDA Holders Must Affirmatively Submit Data To FDA Or Risk Losing Products' Active Listing In The Orange Book
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
United States
19 Jan 2018
2
Bigelow Tea Steams Over Herbicide Charges
The herbicide glyphosate, available in commercial form from Monsanto as "Roundup" since the early 1970s, had by 2007 become the No. 1 herbicide ...
United States
19 Jan 2018
3
Biosimilar Market Developments Continue Apace In 2018
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products
United States
19 Jan 2018
4
2018 SMFP Need Determinations
The 2018 State Medical Facilities Plan (SMFP) was approved by Governor Cooper on December 11, 2017, and has been issued effective January 1, 2018.
United States
19 Jan 2018
5
HHS Creates Conscience And Religious Freedom Division Within ONC
On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).
United States
19 Jan 2018
6
Trump Administration Unveils Its First Bundled Payment Initiative — BPCI Advanced
The Trump Administration has rolled out its first CMS Innovation Center Medicare bundled payment initiative, the Bundled Payments for Care Improvement Advanced (BPCI Advanced).
United States
19 Jan 2018
7
CMS Clears The Way For States To Add Medicaid Work/Community Engagement Requirements
CMS has announced a new initiative allowing states to propose demonstrations to "improve Medicaid enrollee health and well-being through incentivizing work and community engagement."
United States
19 Jan 2018
8
As Marijuana Shops Thrive, California Employers Revisit Drug Policies
News accounts report that thousands of Californians celebrated the first day of 2018 by exercising their new right to legally purchase marijuana for recreational use.
United States
19 Jan 2018
9
Colorado Liquor Law Working Group Releases Report On Changes To Retail Liquor Licenses
On December 29, 2017, the SB 16-197 Working Group released its report to the Senate Business, Labor, and Technology Committee and the House Business Affairs and Labor Committee...
United States
19 Jan 2018
10
HHS Delays Compliance Date For Revised Common Rule
Unless HHS takes further regulatory action to delay the compliance date, research initiated on or after July 19, 2018 will be required to comply with the revised Common Rule.
United States
19 Jan 2018
11
Congress Holds More Hearings On Opioid Crisis And Public Health Threats
A number of recent Congressional hearings focused on the opioid crisis, including the following:
United States
18 Jan 2018
12
Pharma Payments To NJ Prescribers Capped At $10,000 Per Year Under New Rule
Beginning January 16, the amount of compensation that a New Jersey healthcare provider can accept from pharmaceutical manufacturers for "bona fide services," ...
United States
18 Jan 2018
13
Indian Tribes Lack Jurisdiction Over Consumer Protection And Common Law Tort Claims
Jurisdiction is hardly the spiciest of topics we discuss on this blog and yet it definitely qualifies for frequent-blogging status.
United States
18 Jan 2018
14
Growing Support For Legalized Marijuana In New England, Despite Uncertainty
Recent developments in three New England states indicate that popular support for legalized marijuana is growing, even as the federal government reverses the hands-off policy of the previous administration.
United States
18 Jan 2018
15
OIG Issues Letter Declining To Impose Administrative Sanctions For Provision Of Certain Free Drugs
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries.
United States
18 Jan 2018
16
This Year May Be A Game Changer For 340B Drug Discount Program, Take Two
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA's promise to issue...
United States
18 Jan 2018
17
U.S. Trustee Issues Warning To All Participants In The Cannabis Industry: Bankruptcy Relief May Not Be Available, So Don't Let Your Profits Go Up In Smoke
In a recent article, senior officials with the Department of Justice's Office of the United States Trustee (the "UST"), the federal government's watchdog of the bankruptcy system ...
United States
18 Jan 2018
18
EudraVigilance—Safety Signals Pilot Scheme
Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the EMA has recently announced that ...
European Union
17 Jan 2018
19
Federal Appellate Court To Consider Applicability Of CCTA To Indian Tribes
A case currently pending before the U.S. Court of Appeals for the D.C. Circuit challenges the applicability of the federal Contraband Cigarette Trafficking Act ("CCTA") to tribal entities.
United States
17 Jan 2018
20
Increase Proposed For Mississippi's "Tobacco Equity Tax"
Pending before the Mississippi Legislature is House Bill 906, which, if enacted, would increase the "tobacco equity tax" applicable to cigarettes manufactured by non-signatories ...
United States
17 Jan 2018
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