Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. The division revised those levels in August 2019 to 6.5 ppt for PFOS and 5.1

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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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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

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

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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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach. 2019 Dec 13 [cited 2024 Sep 4];122(4):465–72. Nature Reviews Drug Discovery [Internet].

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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

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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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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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

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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Drug Target Review

OCTOBER 12, 2023

Although non-coding variants have been increasingly appreciated for their essential role in controlling gene expression across cell types and tissues, scientists find it difficult to match them to the genes they regulate, the effects on AD-related functions and thus the individual risk of contracting AD. Frontiers [Internet].

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Drug Target Review

SEPTEMBER 4, 2023

2019): CRISPR in Parasitology: Not Exactly Cut and Dried! 2019): Trypanosoma brucei Interaction with Host: Mechanism of VSG Release as Target for Drug Discovery for African Trypanosomiasis, International journal of molecular sciences. (20):1484. 2019): Biological plasticity rescues target activity in CRISPR knockouts, Nature Methods.

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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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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

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

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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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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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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Broad Institute

DECEMBER 13, 2023

“Slide-tags is compatible with virtually any single-cell sequencing assay, and so brings high-resolution spatial information to single-cell measurements of the cell’s genetic sequence and epigenetic regulation as well.”

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Common Sense for Drug Policy Blog

OCTOBER 4, 2024

Many states have banned or are testing for vitamin E acetate because of the 2019 outbreak of e-cigarette or vaping product–associated lung injury (EVALI) (Schauer, 2021). Consumer Protection and Vape Products "The 2021 review of cannabis policy found that states also have limits on ingredients that can be contained in cannabis products.

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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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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2019 Mar 1;55:93–100. 2019 Nov 1;8(6):784–8. Regul Toxicol Pharmacol RTP. 2019 Jun;78:130–41. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. 2018;53(4):519–25. Colatsky T, Fermini B, Gintant G, Pierson JB, Sager P, Sekino Y, et al. Drug Discov Today. 2009 Sep;14(17–18):876–84.

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The Pharma Data

NOVEMBER 20, 2020

adults reported currently using any tobacco product in 2019, with most reporting use of combustible products, according to research published in the Nov. from the CDC in Atlanta, and colleagues used data from the 2019 National Health Interview Survey to examine national estimates of tobacco product use among U.S. FRIDAY, Nov.

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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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The Pharma Data

DECEMBER 12, 2020

Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth). During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

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The Pharma Data

MARCH 29, 2022

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation. Related Information.

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FDA Law Blog: Biosimilars

MAY 31, 2023

On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. Neither the CSA nor regulations promulgated by DEA provide any deadline for issuing a Final Order and Decision.

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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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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule. Nonexempt human subjects research.

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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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The Pharma Data

NOVEMBER 19, 2020

In 2019, 95 000 AIDS-related deaths occurred in children, two-thirds of those deaths in 21 focus countries. In 2019, 95 000 AIDS-related deaths occurred in children, two-thirds of those deaths in 21 focus countries. In 2019, an estimated 36 000 children who were. 850 000 children living with HIV were not.

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The Pharma Data

JANUARY 19, 2021

The authors suggest natural tracr-L regulates autoimmunity. And in 2019, Caribou co-founder and CRISPR pioneer Jennifer Doudna co-authored a Nature Communications paper describing a system of activating and deactivating single guide RNAs using small-molecule ligands.

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Elrig

APRIL 11, 2024

From 2015 to 2019, he was a postdoctoral researcher in Juergen Knoblich’s lab at the Institute of Molecular Biotechnology (IMBA), Vienna, Austria where he designed advanced human brain organoids aiming to recapitulate the architecture and function of the developing brain. He is an outdoor aficionado and loves to climb the highest summits.

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