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. Regulatory background Biocides are regulated primarily by the Biocidal Products Regulation (BPR) (528/2012/EU).

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Drug Discovery World

SEPTEMBER 28, 2023

Probiotics offer a relatively straightforward, minimally regulated avenue to correcting dysbiosis, and a significant market exists already. However, fewer companies have pursued the avenue of regulated therapeutics. Osel is one company leading the charge to bring regulated therapeutics to market.

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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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Drug Target Review

NOVEMBER 27, 2023

Because these proteins have such a profound effect on cells, there is typically a second hurdle of regulation that needs to be overcome to make the proteins. eFFECTOR Therapeutics has developed a novel class of cancer drugs known as Selective Translation Regulator Inhibitors (STRIs), which directly target the eIF4F complex.

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Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. Despite the law requiring the reporting of suspicious orders, the Gazette-Mail reported that between 2001-2012 the board received only two reports , both from Cardinal Health.

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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. This regulation has since been repealed and replaced with Implementing Regulation (EU) 2020/1740 , though many of the provisions and their articles remain the same.

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

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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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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). By Jeffrey N. During this period the estimated total number of such submissions was approximately 26,121.

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Drug Discovery World

MAY 6, 2024

Mazzetti and Schneider give the example of T3 Pharmaceuticals, a University of Basel spin-off that developed a proprietary cancer therapy platform based on regulating and harnessing the natural behaviours of live bacteria. So, in this way there is a cross fertilisation from the bigger companies to newer ones.

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Agency IQ

NOVEMBER 27, 2023

BY WALKER LIVINGSTON, ESQ | NOV 17, 2023 3:55 PM CST Regulatory background Proposition 65 , formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a regulation that requires businesses to provide warnings to California consumers about significant exposures to chemicals that cause cancer, birth defects, or reproductive harm.

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The Pharma Data

AUGUST 20, 2020

US regulators have approved Janssen’s Darzalex (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. . Source link.

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Drug Target Review

JANUARY 5, 2024

and the work reported in: Bosch DE, Jeck WR, and Siderovski DP ‘Self-activating G protein alpha subunits engage seven-transmembrane regulator of G protein signaling (RGS) proteins and a Rho guanine nucleotide exchange factor effector in the amoeba Naegleria fowleri.’ 2012;Chapter 2:Unit2 8. Epub 2012/03/03. 2022;298(8):102167.

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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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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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Agency IQ

SEPTEMBER 22, 2023

In the 1990 amendments to the CAA, Congress established both new requirements and 189 HAPs that the EPA would be required to target for regulation. The EPA began the process to promulgate new standards on January 9, 2012. The CAA requires that the EPA list categories of sources of HAPs, often splitting by industrial group.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 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

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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The Pharma Data

AUGUST 28, 2020

In addition, the consultation – which seeks to amend the Human Medicine Regulations 2012 – will look into ways to protect companies that manufacture and distribute the vaccine, should it cause any harm.

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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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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. That PTE application was submitted to the PTO on July 26, 2012. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. §

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s deep dive into kratom research and regulation here. ]

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

The FDA took an early lead in the evolution of this movement when they launched the Patient Focused Drug Development (PFDD) initiative in 2012. This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP).

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Drug Discovery World

MARCH 7, 2023

Dr Nahla Al Afifi is Director of Qatar Biobank   spoke to DDW about the need for the healthcare industry in Qatar to adjust its infrastructure if it can facilitate its vision of precision health. “There are many components of the health system infrastructure that need to adapt to enable and accommodate precision medicine, including data privacy (..)

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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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Drug Target Review

AUGUST 24, 2023

2012 Feb 1;24(1):107-15. Cell adhesion molecules and their roles and regulation in the immune and tumor microenvironment. Shear forces induce ICAM-1 nanoclustering on endothelial cells that impact on T-cell migration. Biophysical Journal. 2021 Jul 6;120(13):2644-56. Springer TA, Dustin ML. Current Opinion in Cell Biology.

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Broad Institute

OCTOBER 4, 2023

Cech also described his own recent research, published in Science , in which he and colleagues used an epigenetic gene-silencing complex essential for cell differentiation and often deregulated in cancers to demonstrate that RNA, in addition to serving as a messenger, regulates the process of transcription itself.

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DNA RNA Science Protein Expression 52

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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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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FDA Law Blog: Biosimilars

APRIL 30, 2023

112-144 (2012). d) of title 21, Code of Federal Regulations (or any successor regulation); or (ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision.

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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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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

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The Pharma Data

JANUARY 24, 2021

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The FTD is designed to make important new drugs accessible to patients faster.

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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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The Pharma Data

NOVEMBER 10, 2020

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. 2012) Induction of immunological tolerance by oral anti-CD3. Clin Dev Immunol 2012, 425021. Grand View Research August 2018 ( [link] ). Tiziana Life Sciences January 9, 2020 Press Release ( [link] ). da Cunha, A. Shailubhai, K.,

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