Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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Drug Discovery World

FEBRUARY 8, 2023

GSK’s retrospective study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the period 2002 to 2019. The post Study shines a light on representation in clinical research appeared first on Drug Discovery World (DDW).

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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. See AgencyIQ’s analysis of the fees explanatory note correction.]

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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

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

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. New proposed EPA regulations On July 12, 2023, the EPA announced that it was reducing both the DLHS and DLCL.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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Common Sense for Drug Policy Blog

JUNE 24, 2024

The last decade has been characterized by a remarkable dynamism of change in the illicit drug market with the constant introduction of new substances synthesized to circumvent regulation. A review of synthetic cathinones emerging in recent years (2019–2022). This phenomenon has also applied to synthetic cathinones [ 4 , 5 , 6 ].

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Drug Discovery World

OCTOBER 16, 2023

The company was launched in 2019, initially to build on research from the Alzheimer’s Research UK UCL Drug Discovery Institute (UCL DDI). Protoplasmic astrocytes play an active role in neuronal communication through synapses and regulation of neural circuit function, but they change in Alzheimer’s disease and instead become damaging.

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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Drug Discovery World

OCTOBER 17, 2023

In September, the regulator granted fast track designation to Mythic Therapeutics’ investigational cMET-targeting antibody-drug conjugate , MYTX-011. The drugs were developed by Array BioPharma, which has been a wholly owned subsidiary of Pfizer since 2019. This is the second therapy the FDA has approved for NSCLC in recent weeks.

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group.

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. In Wages and White Lion Investments (DBA Triton Distribution) v.

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Drug Discovery World

JULY 1, 2024

million people died from CVDs in 2019, representing 32% of all global deaths 1. The World Health Organization (WHO) reports that cardiovascular diseases (CVDs) are the leading cause of death globally, stating that an estimated 17.9 When this was launched in September 2021, it was supported by a grant of up to $47.5

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. These statements emboldened member states to vote in favor of draft implementing acts denying renewal for both active substances in December 2019.

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Drug Discovery World

JULY 8, 2022

Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. . Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. .

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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Codon

AUGUST 10, 2023

Journal of Theoretical Biology (2019). Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Nature Reviews Molecular Cell Biology (2019). Link Synthetic biology: applications come of age , by Khalil A.S. &

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Drug Discovery World

OCTOBER 31, 2023

The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed. These factors have made regulators reluctant to rely on NfL in benefit-risk assessments of new therapies. 2019 Aug;11(15):1405-1418. doi: 10.4155/bio-2019-0163. Epub 2019 Aug 12.

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KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

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Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

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Drug Discovery World

AUGUST 24, 2023

The movement to decriminalise psilocybin started with Denver, Colorado, in 2019, which became the first US city to decriminalise psilocybin, which led to Colorado voters approving access to natural medicine with Proposition 122. Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

This ties into a broader literature on the innate fakery and manipulated self-representation on social media, with the ubiquitous employment of filters, curated lighting, posed images, and putting forward one’s ‘best self’ (Ross 2019 ; Tiggemann and Anderberg 2019 ; Kotzé et al. dwf_admin Thu, 06/06/2024 - 23:27 Source Gibbs N.

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Drug Discovery World

FEBRUARY 20, 2024

Ther Innov Regul Sci. IEEE Access 2019; 7: 103059-103079. arXiv:1902.03975 [cs.DB] 2019; DOI: 10.48550/arXiv.1902.03975. 2019; 20: 15017–15022. BBC News, [link] (2019, accessed 25 May 2022) Alharby M and van Moorsel A. 2020; 54: 1123-1133. Lentz J, Kennett M, Perlmutter J, et al. 1902.03975. Biomed J Sci Tech Res.

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Drug Discovery World

FEBRUARY 20, 2024

Ther Innov Regul Sci. IEEE Access 2019; 7: 103059-103079. arXiv:1902.03975 [cs.DB] 2019; DOI: 10.48550/arXiv.1902.03975. 2019; 20: 15017–15022. BBC News, [link] (2019, accessed 25 May 2022) Alharby M and van Moorsel A. 2020; 54: 1123-1133. Lentz J, Kennett M, Perlmutter J, et al. 1902.03975. Biomed J Sci Tech Res.

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Drug Target Review

AUGUST 9, 2023

14 TDP-43 is a DNA and RNA binding protein that regulates the expression and splicing of several target transcripts. Stathmin-2 is one of many proteins that appear critical for the growth and stabilisation of axons, most likely by regulating the dynamics of axonal microtubules.

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Perficient: Drug Development

MARCH 26, 2024

Public Sector Regulations : Public sector bodies are mandated to comply with accessibility regulations like the Public Sector Bodies (Websites and Mobile Applications) Accessibility Regulations 2018 in the UK. Meeting the WCAG 2.2 AA standard is essential for compliance.

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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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Common Sense for Drug Policy Blog

JUNE 6, 2024

2018 ; Llewellyn and Tober 2010; Denham 2019 ). 2019 ), who found that their sample’s consumption ‘transcended IPEDs to encompass a much broader cocktail of substances’ (Salinas et al. 2019 : 49) including recreational drugs like cannabis and cocaine (see also Turnock 2021b ). 2014 ; Begley et al. Fincoeur et al.

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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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