Agency IQ

AUGUST 9, 2024

Commission proposes exemptions to UV-328 ban under POPs Regulation The European Commission plans to implement exemptions introduced under the Stockholm Convention’s 2023 ban of UV-328, an ultraviolet-light absorbing persistent organic pollutant (POP). This exemption is in accordance with Article 4(1)b of the POPs Regulation.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Despite these simplification efforts, key documents, like the protocol and the ICFs, still require publication.

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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.

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Regulations FDA Science 52

Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Science Daily: Pharmacology News

AUGUST 12, 2024

New findings document fewer ship tracks, reduced cloud cover, and boosted warming after ship emissions regulations took effect in 2020.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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

AUGUST 2, 2024

What we expect European regulators to do in August and September 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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Regulations Clinical Trials Production International 40

Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Regulations Production Engineering International 40

The Pharma Data

MARCH 5, 2021

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). These documents are available on the company’s website: [link]. Source link:[link].

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 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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Regulations Production Biosimilars Clinical Trials 40

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 2021, the ICH followed this up with a draft principles document on the E6 update.

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Regulations Trials Science Clinical Trials 40

Agency IQ

MARCH 29, 2024

National PFAS water regulations imminent The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

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Regulations Compliance Production Treatment 40

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 $.021 021 per transaction plus.05%

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Regulations Government 40

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 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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Regulations Production Compliance Pharmaceuticals 40

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.

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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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Regulations Biosimilars Clinical Trials Production 40

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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Regulations Clinical Trials Production Biosimilars 40

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Agency IQ

AUGUST 23, 2024

By Scott Stephens, MPA ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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Regulations 59

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 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

SEPTEMBER 1, 2023

EU’s PIC Regulation adds 35 new entries The European Commission’s latest update to the export and import of hazardous chemicals regulation – which implements the Rotterdam Convention on prior informed consent in the EU – includes 27 pesticides and eight industrial chemicals in the list of substances requiring export notification.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation.

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Agency IQ

SEPTEMBER 1, 2023

EPA publishes amendments to PCB regulations The Environmental Protection Agency has finalized a suite of regulations related to polychlorinated biphenyls, including extraction, disposal, and cleanup regulations. PCB-specific regulations are codified in the Code of Federal Regulations. a closed system) uses of PCBs.

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Agency IQ

JUNE 28, 2024

BY AMANDA CONTI A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products. Fill out the form to read the full article.

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Agency IQ

MAY 28, 2024

BY LAURA DIANGELO, MPH A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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FDA Testimonials Regulations Science 59

Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Part 141 and contains the implementing regulations from the act. The SDWA is administered by the EPA at 40 C.F.R.

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The Premier Consulting Blog

FEBRUARY 29, 2024

With the implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the regulatory framework has undergone a major overhaul, with stricter pre-market requirements, increased notified body involvement, and a greater emphasis on clinical evidence.

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Agency IQ

APRIL 26, 2024

BY LAURA DIANGELO, MPH A final rule requiring Laboratory Developed Tests (LDTs) to be regulated as medical devices has obtained clearance from the White House’s Office of Information and Regulatory Affairs today, allowing the FDA to publish the regulation as early as this week.

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Laboratories Regulations FDA 59

Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. Fill out the form to read the full article.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. 21 U.S.C. § 1310.06.

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Agency IQ

AUGUST 25, 2023

PFAS regulation in the E.U. Toward this end, the European Chemicals Agency (ECHA), member states, and the Commission have embarked on regulatory actions under the REACH Regulation to introduce extensive restrictions on the substances. Two high-profile initiatives to regulate PFAS in the E.U. are currently underway.

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Regulations Government Packaging Organic Chemistry 40

Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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FDA Regulations Production Licensing 40

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

MAY 3, 2024

BY LAURA DIANGELO, MPH The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Agency IQ

OCTOBER 12, 2023

What’s new and noteworthy on CDRH’s FY2024 guidance agenda FDA’s Center for Devices and Radiological Health (CDRH), the agency’s medical device regulatory division, today released its latest “guidance agenda” detailing the documents it plans to release in FY2024. Fill out the form to read the full article.

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