FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. By Larry K.

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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 anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. had Part D expenditures on or before August 16, 2022).

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The Pharma Data

MAY 27, 2022

It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”. “We continue to work closely with our U.S. About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the U.S.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. The sales data evaluated was from 2022, which. See AgencyIQ’s analysis of EMA’s milestones.]

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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

OCTOBER 27, 2023

What We Expect the FDA to do in November 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. November is packed with regulatory and industry meetings.

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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. Overall, 2022 phenylephrine retail sales reached $1.8 billion, compared with retail sales of $0.5

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

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Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. Read AgencyIQ’s analysis of the ICH guideline here ].

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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. In September 2022, the FDA held a workshop focused on increasing the efficiency of biosimilar development programs.

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. The Office continues work on a broad array of projects, though not all have been active OCE pursuits.

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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. The December calendar is packed with regulatory and industry meetings.

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Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

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Drug & Device Law

JANUARY 4, 2024

2022) (same result as to other COVID-19 vaccine). Alabama State Board of Pharmacy , 61 F.4th April 13, 2022) (available here ). 2022) (quoting this publication). “The Okuley’s Pharmacy & Home Medical , N.E.3d 25, 2023); Goins v. Saint Elizabeth Medical Center , 640 F. 3d 745, 753 (E.D. 4th 137, 139 (D.C.

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Drug & Device Law

DECEMBER 29, 2023

As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling.

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Drug & Device Law

OCTOBER 25, 2023

We don’t remember what the legislation was about, but we do remember the consumer affairs guy regaling us with stories about how easy it was for state investigators to find all sorts of violations of consumer fraud regulations. Central Admixture Pharmacy Services, Inc. , That isn’t necessarily the result of anything nefarious.

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Drug & Device Law

OCTOBER 10, 2023

Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” Central Admixture Pharmacy Services, Inc., That’s the FDA’s job, not the court’s. Similarly, the court in Nexus Pharmaceuticals, Inc. 48 F4th 1040, 1049 (9 th Cir.

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Drug & Device Law

SEPTEMBER 14, 2023

One particularly long-standing and road-winding issue has been FDA’s authority to discourage, prevent, and discourage the promotion of off-label use of FDA-regulated medical products. As we have pointed out many times, FDA does not regulate the practice of medicine. at *29-30. We agree with that to a degree. at *23 (quoting Texas v.

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Drug & Device Law

FEBRUARY 20, 2023

In at least the short term, a popular pain reliever would have to be removed from pharmacies. 3d , 2022 WL 6225596 (S.D. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. 2022 WL 6225661, at *5 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. Ethicon, Inc. ,

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Drug & Device Law

NOVEMBER 30, 2022

21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene. . The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy. Valisure calls itself “the pharmacy that checks.”

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Drug & Device Law

JULY 18, 2022

United States , 2022 WL 2295024, 142 S. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. At the end of the term, the Supreme Court, in Ruan v.

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Drug & Device Law

JUNE 29, 2022

LLC , 2022 Minn. May 24, 2022), is unusual. The plaintiff cried foul, claiming that the defendant had copied its product, violated Minnesota law regulating pharmaceutical compounding, and defrauded customers. The plaintiff groused that it was improbable that Minnesota would not regulate outsourcing facilities.

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