FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

JANUARY 4, 2024

Citizen petitions have raised the alarm regarding benzene in recent years, leading to FDA action Valisure, an analytical pharmacy that first alerted the FDA to concerns associated with nitrosamine impurities , recently set its sights on benzene impurities. FDA-2023-D-5408

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Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. A few months later in January 2023, the agency released a “ BsUFA Research Roadmap ,” which further outlined the specific action items under the pilot.

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The Pharma Data

JANUARY 24, 2021

Sairiyo recently received FDA orphan drug designation for Cepharanthine in the treatment of esophageal cancer. billion during 2019-2023 (Technavio 2019). The global esophageal cancer drugs market is estimated to grow by USD $1.5

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. On March 21, 2023, the CHPA issued a press statement applauding the FDA’s actions.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

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Drug & Device Law

MAY 26, 2023

Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. Politics makes strange bedfellows. So does the law.

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Drug & Device Law

JULY 24, 2023

3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. the relationship between [plaintiff] and its pharmacy benefit manager. . . Apparently, massive loss of evidence was merely a “usual and customary service” of pharmacy benefit mangers nationwide. 2023 WL 4191651, at *8. 2023 WL 4191651, at *8.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). 25, 2023); Goins v.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

MAY 10, 2023

The FDA, for all of the criticisms leveled against it, has a lot of expertise and energy when it comes to approving drugs and devices. It is simply unworkable, even nonsensical, to permit the states to impose varying, contradictory requirements on FDA-approved products. New Jersey CVS Pharmacy, LLC, 2023 WL 3249820 (D.N.J

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Drug & Device Law

OCTOBER 10, 2023

Luminas Int’l LLC , like this—hey court, it’s not fair that I’m following the FDA’s rules and my competitors are not, so you should force them to do so to even the playing field. 12, 2023). To which the court appropriately said—you’ve come to the wrong place; FDA rules are the FDA’s to enforce. LEXIS 179285 (S.D.

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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Drug & Device Law

NOVEMBER 2, 2023

A court within the Fifth Circuit has held that the FDCA impliedly preempts unfair-competition and consumer-protection claims asserted by a drug manufacturer against a compounding pharmacy. Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D. There is, however, an exception for drugs produced by a qualifying compounding pharmacy.

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