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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Agency IQ

NOVEMBER 10, 2023

Last week, President Biden signed a new executive order on a federal approach to artificial intelligence (AI) regulation. The document outlines sweeping whole-of-government approaches for AI policy, including some direct tasks that are life sciences-related. Fill out the form to read the full article.

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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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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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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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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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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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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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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

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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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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Government Pharma Companies Regulations Drugs 52

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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Regulations Production International Government 40

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). It does not include substances that are governed by other U.S.

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Regulations Government Marketing Research 40

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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Regulations FDA Government Production 45

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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Government Regulations 64

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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Regulations FDA Doctors Government 59

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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Government FDA Biosimilars Regulations 40

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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Clinical Trials Regulations Trials Pharmaceutical Companies 52

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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Regulations Compliance Government Production 116

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

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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Regulations Packaging Production International 40

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

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. However, a producer may also choose to apply for independent compliance with the requirements.

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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

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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Regulations Production Packaging Science 40

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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Government Regulations 52

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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Agency IQ

NOVEMBER 10, 2023

The Artificial Intelligence Executive Order: What does it mean for FDA and its regulated industries? Last week, President Biden signed a new executive order on a federal approach to artificial intelligence (AI) regulation. Quick recap: What an EO is, and what it’s not.

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Regulations FDA Government Science 40

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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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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Regulations Organic Chemistry Government 40

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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Regulations Packaging Production Government 40

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

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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Regulations Compliance Treatment Marketing 52

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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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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