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Goodwin Procter LLP
Last week, FDA released a draft guidance, "Labeling for Biosimilar and Interchangeable Biosimilar Products" ("2023 Draft Guidance") that—when finalized—will revise and replace its July 2018...
Jones Day
On August 22, 2023, the Federal Circuit issued a nonprecedential decision holding that claims directed to deuterated analogs of ruxolitinib were unpatentable as obvious. Sun Pharm. Indus
Reed Smith
A group of conservative Republicans in the House of Representatives' proposed Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 (H.R. 4368)...
Reed Smith
Thelen v. Somatics, LLC, 2023 U.S. Dist. LEXIS 165819 (Mag. M.D. Fla. Sept. 18, 2023), is the latest chapter in a saga we have covered before. (We discussed decisions on expert admissibility here...
Goodwin Procter LLP
Last week, FDA released a draft guidance, "Labeling for Biosimilar and Interchangeable Biosimilar Products" that—when finalized—will revise and replace its July 2018 final guidance...
Holland & Knight
If a business involves any kind of manufacturing or sale of physical products, odds are that it will be impacted one way or another by developments in legislation or case law involving...
Perkins Coie LLP
Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space.
Steptoe & Johnson
When a clearance, exemption or exception won't do, an FCN is for you.
Manatt, Phelps & Phillips LLP
Obesity is a complex, multifactorial disease that has serious health consequences, affects millions of Americans and drives hundreds of billions of dollars in annual health care spending.
Sheppard Mullin Richter & Hampton
On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance")...
Steptoe & Johnson
There are generally two types of analyses for PFAS: (1) an analysis to detect and quantify the presence of specific PFAS, typically around 40 compounds (and varies lab to lab)...
Holland & Knight
In this episode of the "Eyes on Washington" podcast series by Holland & Knight's Public Policy & Regulation Group, Healthcare and Life Sciences attorneys Michael Werner and Sara Klock...
Reed Smith
For example, your humble bloggers spend a lot of time thinking about federal preemption, the other side's never-ending efforts to get around it, and how defense lawyers should respond.
Foley Hoag LLP
After remaining silent on the topic for decades, the FDA provided an expansive definition of "promotional labeling" in its recently issued draft guidance document on Regulatory Considerations...
Ankura Consulting Group LLC
On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.
AlixPartners
With traditional grocery's share of the fresh food dollar on the decline, communication about produce, protein and prepared foods is more critical than ever. In this five-part series...
Butler Snow LLP
On December 27, 2020, the Centers for Medicare & Medicaid ("CMS") of the Department of Health and Human Services created a new provider type for embattled rural...
Jones Day
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable...
Reed Smith
Kulkarni v. Generics, 2023 U.S.Dist.LEXIS 160730 (S.D.N.Y. Sept. 8, 2023), is an interesting generic preemption (mostly) dismissal involving an "old" (pre-1962) drug. A pro se plaintiff sued five affiliated...
Mintz
Although most of the recent focus around the implementation of the Inflation Reduction Act ("IRA") by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program...
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