Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations 59

Agency IQ

JULY 8, 2024

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JULY 22, 2024

BY WALKER LIVINGSTON, ESQ On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond. Fill out the form to read the full article.

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Regulations 59

Agency IQ

MARCH 29, 2024

BY WALKER LIVINGSTON, ESQ The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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Regulations 59

Agency IQ

JULY 8, 2024

Board of Governors, holding that the law allows litigants to challenge agency regulations within six years of being harmed by those regulations, rather than six years from the time the agency finalized the regulations. Fill out the form to read the full article.

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Regulations 59

Agency IQ

JULY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC 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. Fill out the form to read the full article.

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Agency IQ

JUNE 21, 2024

BY KIRSTEN MESSMER, PHD, RAC This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024. Fill out the form to read the full article.

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Agency IQ

MAY 31, 2024

and national regulators. Fill out the form to read the full article. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U.

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Agency IQ

MARCH 29, 2024

National PFAS water regulations imminent The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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Agency IQ

JULY 21, 2023

New EPA regulations to sweep up lead levels in many structures The Environmental Protection Agency has announced new dust-lead hazard standards and clearance levels, which regulate levels of lead dust on floors and windowsills. Fill out the form to read the full article. Dust in the wind?

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Regulations 52

Agency IQ

MARCH 7, 2024

BY COREY JASEPH, MS, RAC This week, the British regulator MHRA offered a new peek into its planned medical device regulations. Fill out the form to read the full article. In the wake of Brexit, the E.U. no longer recognized products certified in the U.K., but the U.K. still needed CE-marked products. but the U.K.

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Agency IQ

MAY 28, 2024

BY COREY JASEPH, MS, RAC The British medical device regulator just issued its promised framework on international recognition. Fill out the form to read the full article.

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Agency IQ

JANUARY 12, 2024

To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. Fill out the form to read the full article.

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Agency IQ

MARCH 29, 2024

and national regulators. Fill out the form to read the full article. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 1, 2024

and national regulators. Fill out the form to read the full article. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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Regulations Science 59

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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Agency IQ

APRIL 12, 2024

BY LAURA DIANGELO, MPH In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In this article, AgencyIQ explores the current regulatory state of decentralized trials and what’s likely coming next.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

SEPTEMBER 1, 2023

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Agency IQ

DECEMBER 1, 2023

In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Agency IQ

MARCH 15, 2024

The newly released draft regulations, statement of reason and regulatory impact assessment all point to the wide-reaching implications that the rule will have for a variety of industries across the state. Fill out the form to read the full article.

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Regulations 59

Agency IQ

OCTOBER 27, 2023

In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Regulations Science 59

Agency IQ

FEBRUARY 23, 2024

Under Section 112(r) of the Clean Air Act, the EPA must publish regulations and guidance regarding chemical accident protection at facilities nationwide. Fill out the form to read the full article.

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Regulations 59

Agency IQ

APRIL 12, 2024

BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Fill out the form to read the full article. There are a wide variety of definitions for PFAS and consistent debate on which definition is most applicable.

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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. Fill out the form to read the full article. This overview will outline the various actions the EPA has taken to address PFAS.

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Agency IQ

AUGUST 30, 2024

Fill out the form to read the full article. This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars and meetings.

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Regulations 52

biobide

AUGUST 18, 2023

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2).

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Agency IQ

AUGUST 11, 2023

Given this significance, it’s worth analyzing its chaotic regulatory history, examining the implications of the risk assessment document itself, and projecting how this controversial active substance is likely to be treated by EU regulators going forward. Fill out the form to read the full article.

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Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Biosimilars Clinical Trials Production 40

Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Agency IQ

JUNE 17, 2024

Fill out the form to read the full article. BY SCOTT STEPHENS, MPA The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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