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.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. and lack accepted safety for use under medical supervision. 21 U.S.C. § 53,688 (Aug.

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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. 72,694, 72,703 (Dec.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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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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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. before such manufacturer signs a Discount Program agreement) and non-binding of their phase-in eligibility if they provide CMS all ownership information by December 8, 2023.

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Codon

FEBRUARY 13, 2024

Fast forward to 2023. Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. These, at least, are deserving of comments, which are due by July 25, 2023.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. billion during 2019-2023 (Technavio 2019).

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DrugBank

NOVEMBER 7, 2023

EDMONTON, CANADA, November 1st, 2023— DrugBank today kicked off their role as a key distributor of the American Society for Health-System Pharmacists’s (ASHP) data. The healthcare community can license ASHP data for use in new or existing software, databases, or websites in formats specific to organisational needs.

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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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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

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Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Areas of expertise included psychiatry, post-traumatic stress disorder, emergency medicine, pharmacy and medication safety, and statistics. See AgencyIQ’s analysis of the draft guidance here. ].

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Sygnature Discovery

NOVEMBER 29, 2023

Over 50,000 people will die of pancreatic cancer in the USA in 2023 (American Cancer Society estimate) and over 9,000 people in the UK. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Sygnature Discovery

NOVEMBER 29, 2023

Over 50,000 people will die of pancreatic cancer in the USA in 2023 (American Cancer Society estimate) and over 9,000 people in the UK. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. Instead, it had everything to do with licensed U.S. pharmacies and wholesalers allegedly flouting the rules.

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Drug & Device Law

MAY 19, 2023

Sorsaia , 2023 WL 3211847 (S.D.W. May 2, 2023) (“ Sorsaia ”), the plaintiff “is the only United States manufacturer of generic mifepristone,” and the defendants are West Virginia state and local prosecutors. Sorsaia , 2023 WL 3211847, at *2. Sorsaia , 2023 WL 3211847, at *4. In GenBioPro, Inc. Didn’t work.

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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. You never need an authorization from a licensed professional to buy pork or fireworks. Politics makes strange bedfellows. So does the law. Weird cases also make weird law. The Supreme Court decision in National Pork Producers Council v.

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. In at least the short term, a popular pain reliever would have to be removed from pharmacies. 2023 WL 1192538 (Mag.

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Drug & Device Law

JANUARY 4, 2024

FDA letter , December 14, 2023 (by Peter Marks, director CBER) (emphasis original). The “result” alleged was that “[a]s of November 10, 2023, Texans have been administered almost 30 million. . . 2023) (finding defendant’s vaccine to be a covered countermeasure; preempting all claims), review denied (Kan. 25, 2023); Goins v.

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Drug & Device Law

MAY 15, 2023

2d , 2023 Wisc. May 2, 2023), and M.T. 3d , 2023 WL 3135662 (Kan. April 28, 2023). 2023 WL 3135662, at *3-5 (detailed PREP Act discussion). 2023 WL 3135662, at *1 (quoting complaint). includ[es] retail pharmacies. They are: Gahl v. Aurora Health Care, Inc. LEXIS 137 (Wis. Walmart Stores, Inc. ,

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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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