Drug Channels

SEPTEMBER 15, 2021

This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. to 1:30 p.m. CLICK HERE TO LEARN MORE AND SIGN UP. d/b/a Drug Channels Institute.

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Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2022 Pembroke Consulting, Inc.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. As Crary ( 2013 , p. 2020;183-213.

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Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Copyright © 2006-2023 Pembroke Consulting, Inc. Plus, assess how companies are internally planning for these changes. d/b/a Drug Channels Institute.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market.

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Agency IQ

MAY 31, 2024

What we expect the EPA to do in June 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. This is what OIRA is currently reviewing.

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Drug Channels

OCTOBER 30, 2023

Copyright © 2006-2023 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

MAY 3, 2024

What we expect the EPA to do in May 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA new chemicals procedural regulations. TSCA risk management rules.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies, January 2006. Available at [link]. [2]

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Agency IQ

NOVEMBER 27, 2023

Its latest report serves as a powerful indicator for what EU chemical regulation is likely to resemble in the coming years should the agency receive sufficient scientific support to meet four regulatory challenges ECHA just can’t solve without further progress from the scientific community.

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Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Sponsors need to carefully consider how they will prove safety and efficacy in a manner sufficient to satisfy the regulators.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

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Agency IQ

JANUARY 12, 2024

BY WALKER LIVINGSTON, ESQ | JAN 8, 2024 9:33 PM CST TSCA and PFAS The Environmental Protection Agency (EPA) implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. The Inventory does not include substances that are governed by other U.S.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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The Pharma Data

MAY 17, 2021

Gunter, MPhil, and his colleagues at the PORTAL research group provides an analysis of the effect of market exclusivity of drugs under FDA’s Unapproved Drug Initiative (UDI). The initiative was shuttered due to concerns that the price of some legacy drugs in the US market was rising while not generating new clinical data on those drugs. .

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Drug Channels

AUGUST 14, 2021

In such a fluid year for medication access and affordability, join influential stakeholders as they innovate on copay program design and operations, identify key trends in market access, patient affordability and the future of the drug pricing and analyze the impact of cost sharing on out of pocket costs and high deductible health plans.

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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. Gallen (HSG), Switzerland.

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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. The FDA will follow these procedures for both agency-initiated operations (e.g., billion for pseudoephedrine.

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The Pharma Data

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. Enquiries: OKYO Pharma Limited.

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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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

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

JUNE 28, 2024

What we expect the EPA to do in July 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. 801.26, OMB Control No. 801.26, OMB Control No. 801.26, OMB Control No.

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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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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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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Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment.

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Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 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. TSCA risk management rules.

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Agency IQ

JULY 5, 2023

BY WALKER LIVINGSTON, ESQ JUN 29, 2023 5:51 PM CDT PFAS, PBTs, and EPA regulation Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals that are used across industrial and commercial products in a variety of diverse applications.

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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). Strategic Market Research Report; Immuno-oncology Assays Market Size, Trend Analysis 2030.

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Drug Discovery World

DECEMBER 29, 2023

Given their role in regulating cellular functions, it comes as no surprise that membrane proteins are the primary targets for the majority of currently marketed therapeutics. Wolters, D., Rögner, M., & Poetsch, A. Molecular & Cellular Proteomics, 5 (3), 444–453.

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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

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

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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The Pharma Data

JULY 8, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK.

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The Pharma Data

DECEMBER 21, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Eur Respir J.

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