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.

Molecular Biology 86

Molecular Biology Therapies Pharmaceuticals Treatment 86

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

JULY 8, 2024

Supreme Court significantly expands time to file lawsuits over agency regulations The Supreme Court has issued its opinion in Corner Post v. In the Dodd-Frank Act, the Federal Reserve was tasked with exploring a cap on interchange fees, and it published Regulation II in 2011 , which set a maximum fee of $.021

Regulations 40

Regulations Government 40

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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Drug Target Review

AUGUST 17, 2023

These antibodies are negatively regulated by the inhibitory IgG receptor, FcγRIIB (CD32B). Dogma suggests inhibition is mediated through the FcγRIIB immunoreceptor tyrosine-based inhibition motif (ITIM), negatively regulating immunoreceptor tyrosine-based activation motif (ITAM)-mediated signalling from activating FcγRs.

International 98

International Therapies Regulations Clinical Trials 98

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.

Regulations 40

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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.

FDA 64

FDA Regulations Marketing Science 64

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

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

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. At Apple, she led executive-level meetings, including with the Chief Operating Officer, regarding regulatory and legal challenges associated with shipping regulated health features.

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Laboratories Compliance FDA Regulations 59

Advarra

NOVEMBER 10, 2022

The proposal “Protection of Human Subjects and Institutional Review Boards” would revise 21 CFR Part 50 and harmonize the FDA regulations to match the 2018 revised Common Rule across several inconsistent areas, including informed consent and continuing review. . Again, this is similar to what HHS regulations currently permit. .

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Regulations FDA Research Trials 52

Perficient: Drug Development

AUGUST 16, 2023

In 2011, Hanes put together a local investment group that purchased the bank from its former holding company, and he became President and CEO of the new bank. Bank Closed By Regulators Almost all bank closures happen on a Friday so that regulators can work all weekend to reopen the bank on Monday.

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Regulations International Compliance 52

NIH Director's Blog: Drug Development

SEPTEMBER 20, 2018

That includes those involved in regulating our appetites and our moods, via a class of G proteins known as inhibitory G proteins (G i ). 2011 Jul 19;477(7366):549-55. For years, rhodopsin has served as an important structural model for understanding GPCRs.

Laboratories 52

Laboratories Research Drugs Regulations 52

Creative Biolabs

JUNE 20, 2022

In a case study, the authors showed how the common gene BRAF mutation V600E discovered in most melanomas, as well as lung and colon cancers, triggers a novel interaction between the protein encoded by BRAF and a redox-regulated protein, KEAP1. Food and Drug Administration (FDA) in 2011.

Therapies 52

Therapies Regulations Drugs FDA 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Regulations Clinical Trials Drugs 52

FDA Law Blog: Biosimilars

MAY 23, 2023

Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

Therapies 59

Therapies Engineering Production FDA 59

Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

Packaging 40

Packaging Regulations Compliance Production 40

Drug Hunter

AUGUST 21, 2023

The BBB is composed of specialized brain endothelial cells that regulate the distribution of molecules into and out of the brain from the blood. Unlike the endothelial BBB, the blood-cerebrospinal fluid-barrier (BCSFB) is made up of epithelial cells that similarly regulate the distribution of molecules between the blood and CSF.

Drugs 206

Drugs Disease Targeted Protein Degradation Screening Hits 206

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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Regulations Compliance Packaging Production 40

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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Packaging Regulations Laboratories Animal Testing 40

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

MARCH 25, 2024

Updates from IMDRF: What’s next for the working groups 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. The group began with regulators from Australia, Brazil, Canada, China, the E.U.,

Science 40

Science Regulations International FDA 40

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.

Science 40

Science Regulations International FDA 40

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

Production 40

Production FDA Therapies Biochemical Assays 40

Agency IQ

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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Regulations Packaging Production Marketing 40

Agency IQ

JULY 28, 2023

The agency has kept the expected publication date for the National Primary Drinking Water Regulation (NPDWR) for six PFAS consistent between the Fall 2022 and Spring 2023 Unified Agendas [for an in-depth analysis on the proposed NPDWR, see this AgencyIQ piece ]. To contact the editor of this analysis, please email Patricia Iscaro.

Regulations 40

Regulations Packaging Compliance Treatment 40

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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Packaging Licensing Licensing Regulations 40

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. 2011 Oct 1;413(1):261–78. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

NIH Director's Blog: Drug Development

MARCH 11, 2014

3] National Diabetes Education Program: Snapshot of Diabetes [4] National Diabetes Statistics, 2011. NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance. Nat Rev Drug Discov. 2013 Aug;12(8):581-94. [3]

DNA 52

DNA Drugs Disease Research Laboratories 52

The Pharma Data

DECEMBER 17, 2020

She joined VMS BioMarketing in 2008 and has served as its president and CEO since 2011. Immune Regulation – U.K.-based based Immune Regulation Ltd. Smiley currently serves as president and CEO of VMS BioMarketing and is a member of the board of directors of life science company, Assertio. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

Common Sense for Drug Policy Blog

JANUARY 1, 2024

Regulations limiting clean needle and syringe distribution are important operational issues to consider if policy changes supporting harm reduction for PWID are to have optimal impact." M for Philadelphia, $46.8 M for Baltimore). dwf_admin Mon, 01/01/2024 - 15:59 Source Ruiz, Monica S.

Treatment 40

Treatment Government Regulations Disease 40

The Premier Consulting Blog

NOVEMBER 20, 2024

Stages of process validation Process validation involves three distinct stages as described in the 2011 FDA guidance, “Process Validation: General, Principles and Practices.”

Small Molecule 52

Small Molecule Drugs FDA Production 52

Agency IQ

JANUARY 4, 2024

But while the ideas proposed by the agency are likely of interest to regulators, the report doesn’t spend much time thinking about how it might improve its processes to benefit external stakeholders. The GGP regulation describes how the agency solicits or collects feedback on guidance documents, including in advance of publication.

FDA 40

FDA Science Regulations International 40

Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2014 ; Begley et al.

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Marketing Drugs Production Pharmaceuticals 40

The Pharma Data

NOVEMBER 4, 2020

From 2003 to 2014, Mr. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B. SOURCE: XPhyto Therapeutics Corp. View source version on accesswire.com: [link].

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