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. 5 USC Sec 702 governs challenges to agency rules, with the statute permitting any person harmed by an agency’s action to pursue the agency in court over the specific harm.

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Drug Target Review

NOVEMBER 13, 2023

Regulating immunosuppression Beyond serving as a genetic on-off switch, Foxp3 controls greater genetic structural change within regulatory T cells, controlling chromatin architecture changes that subsequently guide the functional success of the peacekeeping immune cells.

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Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Drug Discovery World

MARCH 16, 2023

Additionally, a pledge to reform the regulation and approval of medicines, could see rapid approval for companies whose products have already gone through the US or European system and quickly open the UK as a new market.” We need regulation – but we need regulation that is focused on enabling solutions.”

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Drug Discovery World

JULY 18, 2024

Most notably, it calls for responsibility for regulating cannabinoid-based medicines to be transferred from the Home Office to the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA).

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Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Industry wants its products reviewed quickly, efficiently and predictably.

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Drug Discovery World

APRIL 24, 2024

The Federation added: “It is critical that the regulatory frameworks governing the use of AI in research, development and manufacture must be fit-for-purpose, risk-based, non-duplicative, globally aligned, and adequately tailored.

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Science Daily: Pharmacology News

MAY 10, 2024

Researchers describe the risks of deception by AI systems and call for governments to develop strong regulations to address this issue as soon as possible. Many artificial intelligence (AI) systems have already learned how to deceive humans, even systems that have been trained to be helpful and honest.

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Drug Channels

NOVEMBER 30, 2020

Medicaid and Government Pricing Congress. Staying on the pulse of industry trends, policies and changing regulations has never been more crucial. Offer not valid on non-profit/government registrations. December 14-17, 2020 | Virtual www.informaconnect/medicaidgov. Drug Channels, or any of its employees.

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Drug Discovery World

FEBRUARY 6, 2024

The Association of the British Pharmaceutical Industry (ABPI) has published a manifesto outlining what a UK government must do to make the country a great place to research and develop the medicines and vaccines of the future.

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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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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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FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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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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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. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

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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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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). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Drug Discovery World

DECEMBER 14, 2023

However, specific regulations will be needed to cover biodesign tools, which are more specialised AI models that are trained on biological data and provide insight into biological systems). The post The Federation of American Scientists addresses biosecurity risks of AI appeared first on Drug Discovery World (DDW).

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Agency IQ

AUGUST 25, 2023

Bavaria floats resolution in Bundesrat urging “PFAS regulation with a sense of proportion” Germany’s second largest state, Bavaria, has submitted a draft resolution for consideration in the upper house of parliament that urges German Chancellor Scholz’s government to “ensure a risk-based approach is maintained” in Brussels’ pursuit (..)

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Drug Discovery World

OCTOBER 24, 2023

MP : The way I see it, it is the work of researchers to invent technologies, and it’s the role of governments to regulate how they are used. As the use of this technology becomes more widespread, it is important that international governments and associations coordinate to establish regulations that apply all around the world.

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Drugs.com

JUNE 27, 2024

THURSDAY, June 27, 2024 -- As psilocybin mushrooms become the most popular psychedelic in the United States, some states have started to ease regulations on its recreational use. Now, a new report warns that the federal government will have to.

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FDA Law Blog: Biosimilars

JULY 30, 2024

By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Women in Government and Judiciary Roundtable.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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Drug Target Review

NOVEMBER 3, 2023

They identified ZNF800 as a key regulator of the differentiation of a specific gut cell type, the enteroendocrine cells. These hormones regulate digestive processes, like nutrient absorption, appetite, and glucose metabolism. This is like switching the ‘traffic lights’ on or off.”

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. MONTRÉAL, QC – August 31, 2020 – Janssen Inc.,

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Drug Discovery World

JUNE 3, 2024

The vaccines being jointly developed by biopharmaceutical companies BioNTech and Genentech are still undergoing trials and have not yet been approved by regulators.

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The Pharma Data

NOVEMBER 23, 2020

Zhang’s arrest was for “the suspected offense of smuggling goods prohibited by the import and export regulations under the laws of the PRC,” according to a GenScript statement. Human genetic goods are tightly regulated by the Chinese government.

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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.

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Agency IQ

JUNE 28, 2024

BY WALKER LIVINGSTON, ESQ In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. Fill out the form to read the full article.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. An example of limited and minimal risk systems include AI in benign gaming apps and language generators. a synthetic control arm)?

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The Pharma Data

MAY 2, 2023

African Parliamentarians rally to boost life-saving laws, regulations on road safety Parliamentarians, policy-makers and experts from 10 African countries met today to strengthen laws and actions to curb the scourge of road crash deaths.

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Agency IQ

JUNE 7, 2024

BY SCOTT STEPHENS, MPA 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 Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

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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 early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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Agency IQ

MARCH 7, 2024

BY SCOTT STEPHENS, MPA 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. Among the topics: stakeholder cooperation in the context of the green and digital transition.

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biobide

SEPTEMBER 15, 2023

Given the potential harm that chemical pesticides may cause, they are naturally subject to strict regulation. These regulations have a major impact on the agricultural industry , in many cases limiting crop production and reducing income for farmers. In 2021, the UK government introduced new “Maximum Residue Levels”.

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