Drug Channels

DECEMBER 17, 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. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Hospitals Regulations Drugs 98

Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. REACH, CLP, BPR, PIC), scopes (e.g.,

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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

JANUARY 22, 2021

These solutions promote interoperability and help healthcare businesses meet regulations related to health information exchange. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. He introduces us to the Wolters Kluwer drug data solutions. To learn more, download the Wolters Kluwer interoperability stories ebook.

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Regulations Production Drugs 52

Drug Channels

FEBRUARY 7, 2022

You'll be part of the important discussions on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Copyright © 2006-2022 Pembroke Consulting, Inc. Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency.

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Drugs Compliance International Regulations 97

Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. But working at night is not necessarily good for us. dwf_admin Fri, 01/05/2024 - 12:43 Source Hardon A. Chemical 24/7. Chemical Youth. 2020;183-213. Published 2020 Oct 14.

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Pharmacy Regulations Production Marketing 52

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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Drug Channels

FEBRUARY 21, 2023

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 © 2006-2023 Pembroke Consulting, Inc.

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Pharmacy Specialty Pharmacies Licensing Licensing 97

Drug Channels

OCTOBER 6, 2020

Last year, Dr. Scott Gottlieb, a former FDA commissioner, argued that we shouldn’t give up on biosimilars and prematurely regulate prices. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. What’s more, manufacturers of reference products are cutting drug prices to defend their market shares. d/b/a Drug Channels Institute.

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Biosimilars Marketing Regulations FDA 52

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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Compliance Drugs Science Government 98

Drug Channels

JULY 18, 2022

MDRP 2022 is your chance to hear directly from the government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them – You won’t want to miss it! Copyright © 2006-2022 Pembroke Consulting, Inc. Drug Channels, or any of its employees. d/b/a Drug Channels Institute.

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Government Drugs Regulations Pharmaceuticals 75

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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Pharmacy Specialty Pharmacies Biosimilars Licensing 96

Drug Channels

AUGUST 18, 2020

At the same time, antitrust regulators should weigh the impact of hospitals’ growing clout over prescribers of specialty drugs and attempts to steer patients to in-house pharmacies. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Drug Channels

JULY 17, 2023

This annual event provides you and your team unparalleled access to the government regulators creating the rules, policies and regulations, the industry leaders tasked with interpreting them and the manufacturer experts who will be implementing them. Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Government Drugs Regulations Science 40

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

DECEMBER 17, 2020

Last year, Dr. Scott Gottlieb, a former FDA commissioner, argued that we shouldn’t give up on biosimilars and prematurely regulate prices. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. What’s more, manufacturers of reference products are cutting drug prices to defend their market shares. d/b/a Drug Channels Institute.

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Biosimilars Marketing Regulations FDA 52

Drug Channels

AUGUST 21, 2020

As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. Regards, Adam Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. That’s why I’m especially glad to share today’s guest post from Jeremy Docken, Founder and CEO at Kalderos. to 1:00 p.m.

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Compliance Regulations Drugs 52

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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Regulations Government Engineering International 40

Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. Copyright © 2006-2023 Pembroke Consulting, Inc.

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Pharmacy Biosimilars Marketing Production 75

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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Pharmaceutical Companies Regulations Pharmaceuticals Drugs 74

Drug Channels

SEPTEMBER 13, 2021

Thought-leaders and colleagues from federal agencies, bio/pharma manufacturers, consultants, industry trade associations and law firms will gather to discuss key insights on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices.

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Compliance Drugs Regulations Science 75

Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule. This proposal is intended to require all U.S.

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Clinical Trials Regulations FDA Government 52

Drug Channels

AUGUST 9, 2021

Informa Connect’s 26th Annual Medicaid Drug Rebate Program — MDRP 2021 Hybrid — is an important event for government pricing, rebates and regulation, providing direct access to government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them. d/b/a Drug Channels Institute.

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Government Regulations Drugs Therapies 40

Agency IQ

MARCH 15, 2024

The unprecedented volume of comments received during last year’s public consultation means EU regulators have had to resort to exceptional measures in the REACH restriction procedure as they seek to maintain transparency, objectivity and a high level of quality. See AgencyIQ’s in-depth analysis of this restriction proposal here. ]

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Regulations Packaging Production 40

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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Regulations Science Pharmaceuticals Drugs 52

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. The regulation also obliges sharing information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.

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Animal Testing Regulations Production Research 40

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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The Pharma Data

MAY 12, 2021

When the Pediatric Regulation (EC No. 1901/2006) came into effect in 2007, the goal was to create an environment where pediatric medicines could be researched and made available without “studies on children or delaying authorization for adults.” Here, “the submission of PIPs is a binary item,” he said. .

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Compliance Regulations Clinical Trials Science 52

Drug Channels

NOVEMBER 30, 2020

Staying on the pulse of industry trends, policies and changing regulations has never been more crucial. Copyright © 2006-2020 Pembroke Consulting, Inc. The 22nd Annual Medicaid and GP Congress delivers critical updates and industry best practices to effectively contract, report and comply with state and federal healthcare programs.

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Government Pharma Companies Regulations Drugs 52

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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Regulations Packaging Production Doctors 40

FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

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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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FDA Science Regulations Biosimilars 40

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 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. PFAS regulations for drinking water.

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Regulations Compliance Government Production 40

National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

An analysis of reports to poison control centers found a small increase in intentional methadone exposures in the year following the loosening of federal methadone regulations, but no significant increases in exposure severity, hospitalizations, or deaths.

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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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