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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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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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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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

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

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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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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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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FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992 , 1997 , 2002 , 2007 , 2012 , and 2017 —Hyman, Phelps & McNamara, P.C. The memorandum summarizes each section of FUFRA and analyzes the new law’s potential effects on the FDA-regulated industry.

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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

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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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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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

We wrote a memorandum summarizing CMS’ regulation here. It creates the prospect of larger inflation-based rebates, which make up an increasingly large portion of the total amount paid under the Medicaid Drug Rebate Program—more than half since 2012.”

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Broad Institute

JANUARY 19, 2024

The Gal-Mor group had previously analyzed bacterial samples gathered from more than 48,000 people in Israel with salmonellosis between 1995 and 2012. percent of the cases became persistent infections that lingered for months to years.

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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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Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. PNAS (2012).

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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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Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S. PNAS (2012).

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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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Drug Discovery World

JULY 18, 2023

Since its discovery in 2012, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology has revolutionised the biomedicine and cell and gene therapy fields, providing a versatile tool for precise and efficient genome editing.

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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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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos.

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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

SEPTEMBER 29, 2023

What we expect the EPA to do in October 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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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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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here. This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012.

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Perficient: Drug Development

FEBRUARY 22, 2024

In 2012, Jeff Bezos was interviewed and asked if the iPad would be a “Kindle killer.” At that time, their industry was driven by government regulations and tariffs. The choice can come down to who your audience really is and where your North Star points. The Amazon Kindle was released in 2007. We did amazing work together.

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