Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

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Agency IQ

JUNE 7, 2024

European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.

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The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. CMS has created a checklist to assist sponsors in submitting a complete package. 2] Code of Federal Regulations. 3] Code of Federal Regulations. Resources [1] US Food and Drug Administration.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation. for uses under TSCA.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

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The Pharma Data

FEBRUARY 13, 2022

Department of Agriculture (USDA) Food and Nutrition Service’s final rule issued today on transitional nutrition standards for school-based meals, an action that supports ongoing whole-of-government efforts to improve nutrition, reduce chronic disease and help create a healthier food supply for all. Source link: [link].

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Perficient: Drug Development

SEPTEMBER 19, 2023

Ultimately, this will reduce the cost and complexity of moving and copying data while keeping security, governance, and trust standards. Databricks Salesforce and Databricks are expanding their partnership to allow for seamless merging of data from Data Cloud with external Databricks Lakehouse Platform data.

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The Pharma Data

DECEMBER 30, 2020

The British government also decided to start giving as many people as possible a first dose of vaccines, rather than keeping supplies for second shots, expanding the number of people who will be vaccinated. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart.

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

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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

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation.

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The Pharma Data

JANUARY 6, 2021

AstraZeneca has partnered with Serum Institute of India (SII), the world’s largest vaccine manufacturer, for the supply of the vaccine to the Indian Government but also to a large number of low and middle-income countries.

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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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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

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

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

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The Pharma Data

JANUARY 5, 2021

From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction. This includes Certificates to Foreign Governments from the U.S. and internationally. and internationally.

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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

NOVEMBER 3, 2023

Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. [See wide level.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes. DARWIN EU).

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware.

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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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The Pharma Data

MARCH 25, 2021

Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.

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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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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1)

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The regulation of dietary supplements in the U.S. As the name suggests, a synbiotic is a product that seeks “synergy” from its contents.

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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. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

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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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Agency IQ

AUGUST 4, 2023

government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines. government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. Great Britain, and the E.U. member states. and the U.K.

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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Business: Where is the money? When it comes to something as volatile and irregular in terms of regulation as psilocybin, funding is a key component if the field is to expand and progress.

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