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 Target Review

NOVEMBER 13, 2023

Regulating immunosuppression Beyond serving as a genetic on-off switch, Foxp3 controls greater genetic structural change within regulatory T cells, controlling chromatin architecture changes that subsequently guide the functional success of the peacekeeping immune cells. The study was published in Nature Communications.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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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. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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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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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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New Drug Approvals

DECEMBER 3, 2022

2] The Bcl-2 family is most notable for their regulation of apoptosis , a form of programmed cell death, at the mitochondrion ; Bcl-2 and Bcl-xL are anti-apoptotic proteins. 2008): 360–367. Hann CL, Daniel VC, Sugar EA, Dobromilskaya I, Murphy SC, Cope L, Lin X, Hierman JS, Wilburn DL, Watkins DN, Rudin CM (April 2008).

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Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. The first version of the plan, whose goal was reduction of use of pesticides (or “plant protection products, as the plan called them ) was unveiled in 2008 with the aim of cutting pesticide use in half by 2018.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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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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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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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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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022.

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Codon

JULY 17, 2024

In 2008, I began to lurk on do-it-yourself biology forums. I want to see amateur biology thrive, and while a lot of regulations exist for a reason, I’m unconvinced that molecular biology requires all the crazy expensive equipment that has become associated with it.

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Laboratories Engineering Molecular Biology Science 86

Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

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Agency IQ

APRIL 19, 2024

The conduct and infrastructure of clinical trials is heavily regulated, and updates to the methods, approaches, designs, or technologies employed can have regulatory implications. In particular, regulations in both the U.S. In particular, regulations in both the U.S. KEVIN BUGIN will serve as C3TI Director.

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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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Regulations Compliance International Engineering 40

NIH Director's Blog: Drug Discovery

MAY 9, 2019

If successful, such efforts could revolutionize biology by helping us better understand how allosteric proteins reconfigure themselves in the right shapes at the right times to regulate cell signaling, metabolism, and many other important biological processes. 2008 Sep;33(9):420-425. [2] What exactly is an allosteric protein?

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation 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.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub.

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The Pharma Data

DECEMBER 17, 2020

She joined VMS BioMarketing in 2008 and has served as its president and CEO since 2011. Immune Regulation – U.K.-based based Immune Regulation Ltd. Rockwell Medical — Andrea Heslin Smiley was appointed to the board of directors at Rockwell Medical. He spent 27 years at Merck & Co.

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Agency IQ

JANUARY 19, 2024

WALKER LIVINGSTON, ESQ | JAN 17, 2024 8:30 PM CST Background: Clean Air Act and NAAQS Under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) must issue a cornucopia of air quality-related regulations to protect the environment and public health of the country. BY PATRICIA ISCARO, ESQ.,

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes. DARWIN EU).

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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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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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Hospitals FDA Approval FDA Treatment 52

Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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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 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 1, 2023

What we expect the EPA to do in December 2023 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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The Pharma Data

AUGUST 16, 2020

When my daughter was diagnosed with NMOSD in 2008, there were no approved treatment options, and a critical lack of resources and understanding for people living with this disabling disorder. Applications are under review with numerous regulators, including in the EU and China.

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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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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

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Agency IQ

SEPTEMBER 15, 2023

The SCP Regulations define a candidate chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is found on one or more of the authoritative lists specified in section 69502.2(A) A) , or listed by DTSC using the criteria specified in section 69502.2(B). Chapter 54.

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