Science Daily: Pharmacology News

JANUARY 22, 2024

They must also include all the environmental systems that regulate the functioning and state of the planet, namely all systems on Earth we all depend on, irrespective on where in the world we live. This calls for a new level of transnational cooperation, leading experts in legal, social and Earth system sciences say.

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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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NIOSH Science Blog: Drugs

JULY 15, 2024

A Discussion Paper, Streamlining Regulatory Oversight of Respirators Used in Health Care Settings will Improve Worker Protection, was recently published in the National Academy of Medicine’s NAM Perspectives journal by respiratory experts outside of the federal government.

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Perficient: Drug Development

FEBRUARY 29, 2024

Providing this level of access control substantially increases the quality of governance while reducing the workload involved. Tagging can make these assets more seachable, manageable and governable. Geo-coding data with tags to comply with European regulations is also a possible target of opportunity.

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Perficient: Drug Development

APRIL 5, 2025

Data governance helps organizations manage data appropriately.Some customers say data governance is an optional best practice but not a mandatory implementation strategy. Let’s explore why data governance is no longer optional in today’s data-driven world. Learn How Data Governance Impacts Organizations 1.

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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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Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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ACTO

DECEMBER 17, 2024

The Foundation: Governance and Security Successful AI implementation begins with strong platform governance and security standards. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.

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Perficient: Drug Development

AUGUST 23, 2024

If you use Databricks , you probably know that Databricks Unity Catalog is the industry’s only unified and open governance solution for data and AI, built into the Databricks Data Intelligence Platform. Enhanced Query Performance Unity Catalog is well-known as a centralized metastore location in the context of governance.

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Common Sense for Drug Policy Blog

OCTOBER 1, 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):

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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 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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Perficient: Drug Development

AUGUST 15, 2024

Governance factors focus on the organization’s leadership, transparency, accountability, and adherence to ethical business practices.” ESG investing will focus resources on scrips whose underlying companies that follow positive environmental, social, and governance principles. How does it impact me?

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. BY LAURA DIANGELO, MPH With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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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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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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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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Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. This ascertains completeness of the critical data elements definition and hence aid data governance strategy in a wholesome way.

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thought leadership

APRIL 4, 2025

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Pharmaceutical tariffs of 25% have been forecasted causing many global organizations to investigate the consequences of the tariffs on their overall product portfolio.

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Drug Patent Watch

MARCH 4, 2025

Stay up-to-date on regulatory requirements : Familiarize yourself with the latest guidelines and regulations governing pharmacovigilance. Train your team on pharmacovigilance best practices : Ensure that everyone involved in the development process understands the importance of pharmacovigilance.

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DrugBank

APRIL 25, 2024

Focus on building robust systems to manage and analyze a vast array of data types, ensuring top-notch data governance and quality. Security: Strong cybersecurity is non-negotiable to protect sensitive data and comply with international regulations. Data Management: AI thrives on data. In the U.S.,

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Advarra

MARCH 6, 2025

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra draws members from leading academic institutions, government agencies, and clinical research organizations.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. Hyman, Phelps & McNamara, P.C.’s

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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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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. The government asserted additional allegations that are outside our scope.

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Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.

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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 Channels

MARCH 18, 2024

Informa Connect’s Life Sciences Pricing & Contracting USA May 21-23, 2024 | New Orleans Drug Channels readers save 10% with code 24DRCH10* Whether your daily focus is on Medicaid, Government Pricing, 340B, Drug Price Transparency, Commercial Contracting or Chargebacks , we have you covered!

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Perficient: Drug Development

FEBRUARY 12, 2025

The industry faces numerous challenges, including protecting sensitive data, navigating evolving regulations, and outdated legacy systems. To harness AIs potential effectively, its essential to develop a strategy that considers payment regulations to ensure consumer protection , data privacy , and ethical use of AI.

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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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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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Chemical Biology and Drug Design

SEPTEMBER 18, 2023

LRP1 regulates the clearance of Aβ in Alzheimer's disease. An inhibition of Aβ/RAGE-induced activation of MAPK and NOX governs the protection elicited by formononetin against inflammatory and oxidative stress-induced neuronal damage. RAGE activation promotes proinflammatory or proapoptotic cell responses.

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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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