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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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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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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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

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

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

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

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

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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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well. See AgencyIQ’s analysis of the fees explanatory note correction.]

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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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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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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. While 510(k)s are reviewed through the Office of Health Technology level, 513(g)s also include review from the Office of Regulatory Programs and sometimes even the Regulation, Policy, and Guidance staff.

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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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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. In Wages and White Lion Investments (DBA Triton Distribution) v.

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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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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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KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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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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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

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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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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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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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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Common Sense for Drug Policy Blog

JUNE 6, 2024

This ties into a broader literature on the innate fakery and manipulated self-representation on social media, with the ubiquitous employment of filters, curated lighting, posed images, and putting forward one’s ‘best self’ (Ross 2019 ; Tiggemann and Anderberg 2019 ; Kotzé et al. dwf_admin Thu, 06/06/2024 - 23:27 Source Gibbs N.

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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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Common Sense for Drug Policy Blog

DECEMBER 20, 2023

In 2001, both the decriminalization of low-level possession and use of illicit drugs and the Decree-law 183, regulating harm reduction responses, came into effect. Harm Reduct J 16 , 49 (2019). DCRs are among the harm reduction measures detailed. However, the relevant law restricts DCR locations to areas that are not densely populated.

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FDA Law Blog: Biosimilars

OCTOBER 27, 2024

The next step in this shift of policy was FDA’s withdrawal in late 2019 of its 1998 Compliance Policy Guide (“CPG”) 400.400, discussed here. Before enactment of the CARES Act, FDA issued regulations to add, remove, or make changes to OTC monographs based on whether they were generally recognized as safe and effective (“GRASE”).

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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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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. pricing, among other things.

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Agency IQ

OCTOBER 27, 2023

MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans Regulators from the U.S., The regulators suggest that PCCPs need to be transparent, risk-based, bounded and operate throughout the product life cycle. Internationally, regulators are building a framework AI/ML in regulated products.

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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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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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