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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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., This means even if you code the data, the international privacy regulations apply – even if the Health Insurance Portability and Accountability Act (HIPAA) does not.

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Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP).

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Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s Background: MHRA’s reliance on European Commission decisions and the intend to expand recognition to additional regulators The official exit from of the U.K. from the E.U.

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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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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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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Explainer: carcinogen classification in the E.U., Given how influential the U.S.,

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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides 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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FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

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Drug Target Review

SEPTEMBER 8, 2023

This receptor, referred to as retinoic acid receptor alpha (RARα), is recognised for its regulation of gene expression within the nucleus. Enabling T cells to respond to threats To grasp the significance of this discovery, it’s useful to envision the internal layout of a T cell.

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Science Daily: Pharmacology News

DECEMBER 6, 2023

Although this had already been observed in the local universe, an international research team has just revealed the existence of the phenomenon in galaxies which are more than 7 billion years old and actively forming stars, the category to which most galaxies belong.

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The Pharma Data

OCTOBER 30, 2020

The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST). Health Measures in Relation to International Traffic 12.

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on 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.

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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). See ACS, “ Can Breast Cancer Be Found Early?

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Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This blog was co-authored by Carl Aridas and Joel Thimsen. Build a reliable risk management strategy using accurate estimations and predictions.

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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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The Pharma Data

NOVEMBER 10, 2020

Thank you for the opportunity to provide you with an update on the work of the Review Committee on the functioning of the International Health Regulations (2005) during COVID-19. . and in line with Article 50 of the International Health Regulations (2005). official relation to WHO.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Our EU CTR subject matter experts, study teams and clients work together under the internal oversight of the regulatory affairs lead to navigate the ever-evolving EU regulatory environment.

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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

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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Drug Discovery World

JANUARY 5, 2024

New UK authorisation policy draws on international drug approvals The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines.

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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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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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Drug Discovery World

JUNE 7, 2024

Charles River is partnering with internal and external stakeholders, including regulators and leaders from the biopharmaceutical industry to advance this research. A VCG is a data-driven, digital creation based on robust historical study data, parameters, and complex statistical methodology.

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Drug Discovery World

MAY 29, 2024

When the science lines up, execution of BD goals can enable time-appropriate returns to investors, lengthen the runway (time to cash out), and expand the reach of core technologies beyond programs that can be carried out internally. For pharmas, new programs and portfolios from biotech companies offer a way to augment internal research.

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Drug Discovery World

NOVEMBER 8, 2023

To help inform this collaboration, the report identifies successful examples of processes and schemes that help to facilitate access to rare disease drugs in comparable OECD countries that could become international best practice, including in the UK.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 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.

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thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 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.

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Drug Discovery World

JULY 18, 2024

The report ‘How to Make the UK the Global Leader in Cannabinoid R&D’ in based on contributions from biotech companies including Ananda Developments, Artelo Biosciences, Curaleaf International, Kingdom Therapeutics, NW Pharmatech, Oxford Cannabinoid Technologies, Phytome Life Sciences and Brains Bioceutical.

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Agency IQ

MARCH 25, 2024

BY LAURA DIANGELO, MPH At the International Medical Device Regulators Forum (IMDRF) annual meeting in Washington, DC, regulators presented updates on the work underway within all seven IMDRF working groups. Here, AgencyIQ provides highlights from these updates, including current and future project plans.

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Drug Discovery World

NOVEMBER 3, 2023

First spaceflight mission for drug development lab Redwire will launch its in-space pharmaceutical manufacturing platform, PIL-BOX, onboard SpaceX’s 29th cargo resupply services mission (SpaceX-29) for NASA to the International Space Station (ISS).

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Drug Discovery World

JUNE 15, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. Regulation is necessary, but optimising timescales would be ideal.

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Chemical Biology and Drug Design

JANUARY 15, 2024

The expression levels of endoplasmic reticulum (ER) stress-related protein and silent information regulator 1/nuclear factor kappa-B (Sirt1/NF-κB) signaling pathway were used to observe the therapeutic effect of naringin.

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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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Drug Discovery World

AUGUST 27, 2024

Sustainability is rising to the top of the global agenda as regulations are evolving and investors, customers, and talent demand more transparency from companies on the topic. The research includes insights from executives in 18 countries. 62% of respondents identified sustainability as their number one priority over the next five years.

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Agency IQ

JUNE 17, 2024

These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. BY COREY JASEPH, MS, RAC The European Commission recently adopted its latest version of the medical device and diagnostics standardization request, with help from European standards organizations.

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