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

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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New Drug Approvals

SEPTEMBER 29, 2024

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. In January 2023, Quince put out word that it had sold Cortexyme’s legacy small molecule protease inhibitor portfolio to Lighthouse Pharmaceuticals, a company co-founded by a former Cortexyme CEO ( press release ). 2009 Mar;77(3):1246-61.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

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The Pharma Data

DECEMBER 18, 2020

This commitment is evidence that the world learned an important lesson from the 2009 H1N1 pandemic. It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Our research and development efforts have begun to pay off.

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LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g., Chapter 1 – An Unreasonable Idea The year was 2009.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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The Pharma Data

DECEMBER 3, 2020

About Takeda Pharmaceutical Company Limited. Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Minerva Med.

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Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. Let’s dive into the intricacies of pharmaceutical negotiations, exploring valuable lessons, current trends, and strategies for success.

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Drug Target Review

NOVEMBER 7, 2024

Agonist antibodies of immune checkpoint regulators These represent a groundbreaking class of immunotherapeutic agents that mimic the natural function of endogenous ligands by binding to specific cell-surface receptors. This approach augments the strength of achieving immune homeostasis.

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Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug & Device Law

FEBRUARY 15, 2024

Additionally, if applied retroactively, the revisions would impose a new duty on pharmaceutical drug manufacturers and sellers at the time the injury occurred, where none had existed before. 2009) (citations omitted). It’s also worth noting that Michigan state Senator Jim Irwin, who sponsored S.B. Unibar Maintenance Servs., at 813).

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Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Janssen Pharmaceuticals, Inc. , 3d 709 (Pa.

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Drug & Device Law

OCTOBER 23, 2023

Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ). 662, 684-85, 686 (2009) (citations, including to Twombly , omitted). Ortho Pharmaceutical Corp. , at 328 (citation omitted). Ashcroft v. 2d 352 (Ill.

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Drug & Device Law

AUGUST 31, 2023

The court dismissed the design-defect claim as pleaded, holding it impliedly preempted under Mutual Pharmaceutical Co. Ortho-McNeil-Janssen Pharmaceuticals, Inc. , As for the claims asserted against the manufacturer, some were dismissed while others were not. Bartlett , 570 U.S. 2023 WL 5437356 at *7­. 2023 WL 5437356 at *7­.

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Drug & Device Law

AUGUST 25, 2023

555 (2009). Starting with the initial mumps vaccine approval in 1967, the FDA extensively regulated the vaccines’ labeling. The Krahling opinion provides a good reminder that the regulatory history for an on-market pharmaceutical, device, or vaccine is not static. Albrecht, 139 S. 1668 (2019)and Wyeth v. Levine , 555 U.S.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , 2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. at 77 (citation omitted).

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Drug & Device Law

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. University of Delaware , 2009 WL 5176218, at *2 (Del. 24, 2009); Scaife v. Astrazeneca LP , 2009 WL 1610575, at *14 (Del. June 9, 2009); Podrasky v. Johnson , 2009 WL 6763768 (Minn. Cooper , 496 P.3d

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Drug & Device Law

FEBRUARY 20, 2023

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices. Pizzitola v. Ethicon, Inc.

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Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 555 (2009), and rated only a “ cf. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. citation in PLIVA, Inc.

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. Bayer Healthcare Pharmaceuticals Inc. The FDA also promulgated an acetaminophen-specific OTC regulation. 14, 2022), leaves us scratching our heads.

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Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. Mensing, 564 U.S.

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Drug & Device Law

MARCH 25, 2022

The FDA’s April, 2009, formal “complete response letter” authorized the adverse reaction change, but not the precaution revision, due to insufficient data for the latter, and also turned down “stress fracture” as a description of the risk. 555 (2009). 604 (2011), and Mutual Pharmaceutical Co. Levine , 555 U.S. Answer: yes.

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