Searching Content indexed under Food and Drugs Law by Mintz ordered by Published Date Descending.
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Evolution & Revolution: Device Policy Priorities At FDA In 2019
This post is the first in a series of three in which we recap the Food and Drug Administration's somewhat difficult year
United States
9 Dec 2019
Key Vote In FDA Commissioner Confirmation Process Set For December 3rd
The Senate Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration's nominee to head the Food and Drug Administration (FDA)
United States
4 Dec 2019
First Indicators Of FDA's Policy Decision On CBD And Cannabis-Derived Ingredients: "Only Limited Data" And "Real Risks"
We have previously blogged about the Food and Drug Administration's year of listening and information gathering related to products containing cannabis or cannabis-derived compounds since the 2018
United States
2 Dec 2019
CMS Ignores The Courts: 2020 Hospital Outpatient Prospective Payment System Final Rule Includes 340B Rate Cuts Already Ruled Unlawful
The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, ...
United States
21 Nov 2019
FDA Issues Drug Shortage Report Identifying Root Causes And Potential Solutions
Despite congressional attention, Food and Drug Administration (FDA) action, public and private sector efforts
United States
18 Nov 2019
5 Key Reasons To Ensure Ongoing Compliance With State Distributor Licensing Requirements
Manufacturers and other drug developers should be cognizant of the fact that proper licensing is required in order to distribute prescription drugs.
United States
12 Nov 2019
The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy And Puts Industry On Notice Of Further Regulatory Pressure
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years...
United States
7 Nov 2019
HHS Proposes Sweeping Changes To AKS And Stark Law, Part 1: Value-Based Arrangements
As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) ...
United States
28 Oct 2019
Do You Want Fries With That?
The old joke of "what do Philosophy majors ask at their first job?" takes on a new meaning in the world of Prop 65.
United States
24 Oct 2019
HHS Files Brief In D.C. Circuit Supporting Drug Pricing Transparency Rule
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court's
United States
8 Oct 2019
FTC Identifies Concerns With Plaintiff's Lawyers Advertisements Concerning Risks Associated With Pharmaceutical Drugs
I suspect that we've all had this experience. You've finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show.
United States
4 Oct 2019
GAO Report Sheds Light On Drug Manufacturers' Expanded Access Programs
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside...
United States
23 Sep 2019
GAO Studies Use Of PBMs In Medicare Part D
GAO recently released a report analyzing the use of pharmacy benefit managers ("PBMs") and efforts to manage drug spending and use in the Medicare Part D program
United States
28 Aug 2019
HHS Drug Pricing Disclosure Rule: Chance At A Renewed Life Following District Court Appeal?
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court.
United States
28 Aug 2019
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
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