Drug Channels

DECEMBER 19, 2022

Copyright © 2006-2022 Pembroke Consulting, Inc. The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc., Drug Channels, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@drugchannels.net). d/b/a Drug Channels Institute.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug Channels

SEPTEMBER 29, 2020

As managing copay programs continues to be significantly more complex, it is imperative to stay on top of current trends, emerging regulations and future legislation. Copyright © 2006-2020 Pembroke Consulting, Inc. It’s time to talk. Offer not valid on workshop-only or non-profit registrations. Drug Channels, or any of its employees.

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Drug Channels

OCTOBER 12, 2020

Join Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress to discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Copyright © 2006-2020 Pembroke Consulting, Inc. Other restrictions may apply. d/b/a Drug Channels Institute.

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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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The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011. the world’s largest food company, since 2015.

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The Pharma Data

SEPTEMBER 9, 2020

Additional applications are under review with numerous regulators, including in the EU and China. Patients with AQP4-IgG seropositive or seronegative neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with AQP4-IgG seropositive NMOSD were enroled. Europe and Japan. Europe and Japan.

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The Pharma Data

AUGUST 16, 2020

Patients with aquaporin-4 (AQP4) antibody positive or negative neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with AQP4 antibody positive NMOSD were enrolled. Applications are under review with numerous regulators, including in the EU and China. About neuromyelitis optica spectrum disorder (NMOSD).

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New Drug Approvals

JANUARY 9, 2024

2006 Mar 1; 20(5):601-12, 2006), in contrast with CDK9, which phosphorylates both Ser-2 and Ser-5 of the CTD heptad (Pinhero et al., In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. 1004-1014, 2004). Oct 1 5;24(20):2303-16, 2010; Blazek et al., Konig et al., Cancer Res.

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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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Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Agency IQ

APRIL 19, 2024

Draft guideline modernizes EMA recommendations on quality of inhaled, nasal products The EMA has published a draft revision to its 2006 guideline on product development quality considerations for inhaled and nasal products. In 2006, the EMA published a guideline for developers regarding the pharmaceutical quality of these products.

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Production Pharmaceuticals Regulations Drugs 40

Agency IQ

JUNE 9, 2023

In 2006, the ICH released its S8 Guideline on Immunotoxicity Studies for Human Pharmaceuticals , which provided recommendations on how companies should test pharmaceuticals for “unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.”

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Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. 90, 297–339 (2006). This continues to be the standard of care. Science 271, 1734–1736 (1996). Korman, A. & Allison, J.

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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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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

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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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Regulations Compliance Science Marketing 40

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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Regulations Compliance Government Science 40

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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FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006), aff’d , 279 F. at 77 (citation omitted). In United States v. Brown , 348 F.3d

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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 ). Ortho Pharmaceutical Corp. , 2006); Doe 1 v. at 328 (citation omitted). at 329 (citation and quotation marks omitted) (emphasis original).

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Drug & Device Law

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , 2006); accord Grondin v. 2006) (quotation marks and footnotes omitted). Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. Cooper , 496 P.3d 3d 430, 431-32 (Colo. 2021) (quoting Daubert v. 579, 597 (1993)). See Bocian v. Owners Insurance Co. , 3d 502, 513 (Colo. Prentice v.

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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. ,

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. the state action would be preempted.

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Drug & Device Law

FEBRUARY 20, 2023

2006), app. 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.

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Drug & Device Law

JANUARY 17, 2022

we use[] a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command. Thus, we’re pleased to bring to your attention Pharmaceutical Care Management Association v. 470, 485 (1996). 702 in a non-prescription medical product case. Wehbi , 18 F.4th

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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. It’s also worth noting that Michigan state Senator Jim Irwin, who sponsored S.B. This defies logic, fairness, and – unsurprisingly – due process.

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Production FDA Approval Compliance FDA 52

Drug & Device Law

SEPTEMBER 22, 2023

It is fair to say that Bexis co-founded this blog (in 2006!) in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 604 (2011), and Mutual Pharmaceutical Co. Federal preemption involving OTC drugs is the subject of today’s musings. 379r(a)(1). 379r(a)(1).

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