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.

Regulations 40

Regulations Production Packaging International 40

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.

Regulations 40

Regulations Production Packaging Treatment 40

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.

Laboratories 59

Laboratories Compliance FDA Regulations 59

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.

Regulations 40

Regulations Compliance Production Government 40

Drug Target Review

JULY 24, 2023

Researchers from Tokyo Tech’s World Research Hub Initiative conducted a study to investigate the regulation of gene expression in the apicoplast of the malaria parasite Plasmodium falciparum. How is melatonin, the circadian signalling hormone, related to the regulation of gene expression in the apicoplast?

RNA 98

RNA Regulations Bioinformatics Laboratories 98

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Regulations 64

Regulations FDA Marketing Science 64

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.

Regulations 40

Regulations Compliance Packaging Production 40

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

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.

Regulations 52

Regulations International Compliance 52

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. .

Regulations 52

Regulations FDA Research Trials 52

FDA Law Blog: Drug Discovery

FEBRUARY 5, 2024

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. By Deborah L.

Clinical Trials 59

Clinical Trials Trials FDA Production 59

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

Broad Institute

MARCH 14, 2024

In the new study, the researchers used a system called phage-assisted continuous evolution (PACE), first developed in Liu’s lab at Harvard in 2011, to generate a degron that might work with PT-179. Continuous evolution of compact protein degradation tags regulated by selective cereblon molecular glues. Paper cited Mercer JAM, et al.

Targeted Protein Degradation 141

Targeted Protein Degradation Small Molecule Medical Schools Science 141

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

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

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 Regulations Therapies Clinical Trials 98

Codon

AUGUST 10, 2023

Nature (2011). 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.

DNA 98

DNA Cell Biology Molecular Biology Engineering 98

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.

Packaging 40

Packaging Regulations Laboratories Animal Testing 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

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

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.

FDA 45

FDA Compliance Regulations Production 45

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

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.

FDA 52

FDA Regulations Clinical Trials Production 52

Drug Discovery World

DECEMBER 6, 2022

Detailed meta-data (the data about data) is a requirement of working in a regulated industry – enabling reproducibility and traceability. Stat Methods Med Res 2011; 20(6):613-22. 10 As a result, reported cumulative Covid-19 deaths reduced by 13% overnight. . Clinical Data Interchange Standards Consortium. Smith M, Marshall A.

Drug Development 246

Drug Development Vaccine Drugs Pharmaceuticals 246

Agency IQ

MAY 10, 2024

The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. However, pesticide regulation has remained a political flashpoint in France, where EU environmental regulations may be not only upheld, but sometimes supplemented with further domestic requirements.

Government 40

Government Regulations Production Marketing 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.

Marketing 40

Marketing Drugs Production Pharmaceuticals 40

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 FDA Research 52

The Pharma Data

APRIL 7, 2023

The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study.

FDA 40

FDA FDA Approval Production Vaccine 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.

Regulations 40

Regulations Packaging Production International 40

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

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 Government 40

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

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.

Packaging 40

Packaging Licensing Licensing Regulations 40

Codon

AUGUST 10, 2023

Nature (2011). 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.

DNA 52

DNA Cell Biology Engineering Molecular Biology 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

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 Regulations Drugs 52

Drug Discovery World

FEBRUARY 22, 2024

According to Alzheimer’s Research UK (ARUK): “In the UK, dementia was the leading cause of death in 2022 and has been the leading cause of death for women since 2011 – maintaining its position throughout the Covid-19 pandemic. They focused on miRNAs, which regulate multiple target proteins controlling the cellular processes in the amygdala.

Drugs 147

Drugs Clinical Trials Disease Therapies 147