Searching Content indexed under Food and Drugs Law by Mintz ordered by Published Date Descending.
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Congress Looking To Streamline CBD Drug Research
We've previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD
United States
16 Aug 2019
CMS Takes Another Swing At 340B Reimbursement Cuts. Will It Be Strike Three?
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications
United States
15 Aug 2019
Open Payments Program Expansion
On July 30, 2019, the Centers for Medicare & Medicaid Services ("CMS") announced more proposed changes to the Open Payments Program.
United States
13 Aug 2019
In Policy Reversal, HHS And FDA Propose Plan To Import Foreign Drugs
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan
United States
12 Aug 2019
Senate Finance Committee Passes Drug Pricing Bill
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest
United States
5 Aug 2019
ML Strategies Health Care Preview - Week Of July 29, 2019
This week, the Senate is expected to consider the House-passed two-year budget deal that will also suspend the debt limit for two years.
United States
2 Aug 2019
FDA Invites Compounding Outsourcing Facilities' Comments To Understand Industry Challenges And Opportunities
On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609).
United States
2 Aug 2019
Software Update: The Latest On FDA's Pre-Cert Pilot
Regular readers of this blog know that we're closely following the FDA's proposed regulatory framework for software as a medical device (SaMD), known as precertification
United States
26 Jul 2019
Trump Administration Withdraws Proposed Rebate Rule
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor
United States
19 Jul 2019
Third Circuit Dismisses FCA Case Under Pre-ACA Version Of Public Disclosure Bar
The Third Circuit Court of Appeals recently dismissed a relator's False Claims Act ("FCA") case under the pre-Affordable Care Act ("ACA") version of the public disclosure bar.
United States
18 Jul 2019
Federal Judge Strikes Down Hhs Drug Pricing Disclosure Rule
In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration's rule
United States
17 Jul 2019
ML Strategies Health Care Preview: ACA Oral Arguments To Begin
Welcome back. This week, the Senate Finance Committee is set to meet privately to discuss the drug pricing legislation being developed by the committee
United States
16 Jul 2019
Pharmaceutical Companies Object To HHS Drug Pricing Disclosure Rule
Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule...
United States
4 Jul 2019
OIG Report Finds A Small Percentage Of Hospitals Do Not Obtain Compounded Drugs From FDA-Registered Outsourcing Facilities
On June 6, 2019, the U.S. Department of Health and Human Services' Office of Inspector General issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific compounded drugs ...
United States
21 Jun 2019
Heritage Pharmaceuticals Admits To Generic Drug Price Fixing Scheme
The May 30th charge is not Heritage's first brush with DOJ's generic price-fixing investigation.
United States
21 Jun 2019
Navigating The Legalization Of Hemp Under The 2018 Farm Bill Involves Changes To The Issuance Of Federal Trademarks In The Cannabis Industry
Legalizing "hemp" under the Agricultural Improvement Act of 2018 has triggered an important change for the examination of federal trademark applications concerning cannabis and cannabis-derived goods and services.
United States
21 Jun 2019
Cannabis-Derived Ingredients In FDA-Regulated Products: More Questions Than Answers At FDA's May 2019 Public Hearing
As most folks with any interest in the burgeoning cannabidiol (CBD) industry likely know, on May 31, 2019, the Food and Drug Administration held a public hearing "to obtain scientific data
United States
17 Jun 2019
Federal Circuit Affirms That The ITC Cannot Investigate An FDCA Violation Without The FDA's Say-So
In Amarin Pharma, Inc. v. Int'l Trade Comm'n (18-1247), the Federal Circuit affirmed the International Trade Commission's ("ITC") finding that Amarin's false advertising claim under § 43(a) of the Lanham Act was precluded by the Federal Food, Drug, and Cosmetic Act
United States
13 Jun 2019
Maryland's Prescription Drug Affordability Board Bill Set To Take Effect
In the ongoing public dialogue about prescription drug affordability, Maryland seems poised to lead the way for states considering a new way to rein in drug spending: drug affordability boards. This spring, the Maryland General Assembly passed
United States
10 Jun 2019
CMS Finalizes Medicare Advantage And Part D Drug Pricing Rule
Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D.
United States
10 Jun 2019
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