Searching Content indexed under Food and Drugs Law by Mintz ordered by Published Date Descending.
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Dueling Declaratory Judgment Suits Result In A Dismissal And Boomerang Transfer Back To The First-Filed Forum Under TC Heartland
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court
United States
16 May 2019
ML Strategies Health Care Preview Week Of April 29, 2019
Welcome back. This week will focus largely on "Medicare for All" proposals. The House Rules Committee will hold the first hearing on the subject this Congress
United States
15 May 2019
FDA And Outgoing Commissioner Scott Gottlieb Open Up About Cannabis And CBD Regulation
As predicted by our colleagues earlier this month, outgoing Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) released a comprehensive press release.
United States
8 May 2019
FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent
Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI's Cosmetics & Personal Care Products conference on March 28, 2019.
United States
8 May 2019
MLS Weekly Preview: Congress Keeping Its Focus On Drug Costs
This week, Congress will continue to look at lowering health costs.
United States
23 Apr 2019
CMS's New Part D Policies Address The Opioid Epidemic
In recent months, we've highlighted several changes that CMS is implementing to combat opioid misuse. In this post, we focus on CMS's new Medicare Part D Opioid Overutilization Policies.
United States
17 Apr 2019
New York (Again) Seeks To Regulate Pharmacy Benefit Managers
On January 15, 2019, Governor Cuomo released the 2019-2020 Executive Budget, which proposes substantial legislative changes that would affect pharmacy benefit managers (PBMs).
United States
27 Mar 2019
March 2019: Where Are We Now With 340B?
Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program.
United States
11 Mar 2019
Device Modernization Series: FDA's Proposed De Novo Regulation
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program.
United States
8 Mar 2019
What Does The Future Hold For Drug Pricing?
On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices.
United States
8 Mar 2019
Five Takeaways From The Senate Finance Committee's Hearing On Drug Pricing
On February 26, 2019, the Senate Finance Committee heard testimony from top executives representing seven high-profile drug manufacturers.
United States
7 Mar 2019
ML Strategies Health Care Preview - Week Of February 25th
This week, Congress will dive into rising prescription drug costs with a hearing in the Senate Finance Committee.
United States
6 Mar 2019
CMS Continues To Combat The Opioid Epidemic
Last month, we highlighted a few of the changes CMS proposes in Parts I and II of the Advance Notice and Draft Call Letter. Here, we take a look at CMS's next steps to combat opioid misuse.
United States
1 Mar 2019
ML Strategies Health Care Preview - Week Of February 11, 2019
With Valentine's Day approaching, love may be in the air - but not so much on Capitol Hill.
United States
19 Feb 2019
45 States Now Have Biosimilar Substitution Laws
Forty-five states and Puerto Rico have now enacted laws that permit or require pharmacists to dispense an interchangeable biological product in certain situations.
United States
18 Feb 2019
OIG Advisory Opinion Allows Smartphone Loan For Needy Patients Taking Digital Drug
Last week, the OIG for the DHHS issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer to loan a limited-use smartphone to financially needy patients taking the digital version of...
United States
11 Feb 2019
ML Strategies Health Care Preview - Week Of February 4, 2019
The long-awaiting safe harbor proposed rule was published last week as the Administration looks to get out in front of the drug pricing debate ...
United States
8 Feb 2019
HHS Proposes To Remove Drug Rebate Protections
The proposed effective date for the discount safe harbor amendment is January 1, 2020.
United States
7 Feb 2019
Part D Payment Modernization Model Aimed At Reducing Medicare's Catastrophic Phase Spending
CMS indicated that additional programmatic flexibilities will be provided to model participants.
United States
31 Jan 2019
CMS Addresses Drug Manufacturer Coupons In Proposed 2020 Payment Notice
Comments must be received no later than 5pm on February 19, 2019.
United States
30 Jan 2019
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