Drug Discovery World

MARCH 27, 2023

The UK government endorses TREs, having recently announced an investment package of up to £200 million in TREs and digitally enabled clinical trials 4. OFH launched a TRE accreditation process in January 2023, which shows great promise in establishing common requirements for platforms, data governance, security, and privacy.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

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Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Agency IQ

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. years for fluoropolymers used in food and feed packaging for industrial and professional use, to 1.5 Under the current proposal, the transitions would range from 13.5

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Drug Discovery World

FEBRUARY 22, 2023

At the same time government agencies will push to supply these treatments at the lowest possible cost, putting increasing pressure on big pharma. Consumer awareness will catch up with what is happening beyond the appearance of the product packaging, and they will start to exercise their choices to influence the manufacturing practices too. 

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The Pharma Data

OCTOBER 29, 2020

These immense benefits can be achieved through investment in five proven and cost-effective intervention packages recommended by WHO to address the major NCD risk factors. . The results of the analysis show that by scaling up the national NCD response, the Russian Government can continue to improve the situation in the country. .

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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. only” label can be affixed anywhere on the packaging.

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The Pharma Data

JUNE 18, 2023

These include implementing small-scale regional or state-wide programmes on improving access to morphine for medical use with a package of essential services and products for palliative care that is formulated according to the WHO Model List of Essential Medicines and the WHO Essential Package of Palliative Care.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. CluePoints provides clinical studies with risk management support package during Covid-19. Dr. Francis S.

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Drug Discovery World

AUGUST 10, 2023

SG: We are in the early stages of the “data connectivity” period, where critical data from various functions (regulatory, quality, manufacturing, safety, clinical, etc ) are gradually being connected. This requires a clear focus and excellence around cross-functional data governance.

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Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. However, Maine (and some other states) have more broadly focused on banning all intentionally added PFAS in products after a certain date.

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Drug Discovery World

FEBRUARY 10, 2023

For instance, in Sweden, a project to help advance the development of ATMPs using artificial intelligence-based quality control methods has been launched by government agency Vinnova. Novo Nordisk remains the largest companies in Medicon Valley with 19,000 employees across Denmark and generating a turnover of 140 billion DKK.

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The Pharma Data

AUGUST 7, 2020

Ministers say they were working with unions to ensure the “best possible” pay package for all health workers. “So for the government to exclude us from a pay rise is awful – a real kick in the teeth.” The current agreement is said this year to have seen the average nurse receiving an average increase of 4.4

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Agency IQ

APRIL 12, 2024

Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Heated debates on the most contentious issues resulted in a compromise text for each legislation in March The proposal package , consisting of one directive and one regulation, was finally released in April 2023. citizens; 2.

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Drug Discovery World

AUGUST 24, 2023

However, in June 2023, the Government of Canada invested nearly $3 million to study the potential benefits of psilocybin-assisted psychotherapy 4 , indicating the country’s journey towards an end-goal of safe, legalised psilocybin use in the country. million of the investment is dedicated to mental health research 7.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”

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Perficient: Drug Development

DECEMBER 20, 2023

With on-prem AEM installations, you could have a separate repository for each tenant website, where you would just install a separate code package for each tenant (be it manually in the Package Manager or via a CI/CD pipeline in a tool of your choice). It will install code packages for each of the submodules.

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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.

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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?

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Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

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The Pharma Data

OCTOBER 30, 2020

A three-way agreement between Takeda , Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW) plans to bring mRNA-1273, Moderna’s Covid-19 vaccine candidate, to Japan. Takeda and Moderna join forces to expand Covid-19 vaccine supply in Japan. Source link.

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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.

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Agency IQ

MAY 3, 2024

It aims to: strengthen ECHA governance and adapt it to its future role, as well as to streamline the working methods of ECHA bodies and make their financing more sustainable. food packaging, kitchen and tableware and food processing equipment). EU food safety policy includes rules on food contact materials (e.g.,

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Perficient: Drug Development

JULY 20, 2023

If you’re leading the industry, your company is taking an assertive approach to security strategies and governance of data and technical infrastructure across the entire organization and throughout the whole life cycle of the customer.

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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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FDA Law Blog: Biosimilars

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. With the ambiguity of the statutory text, FDA looked at the plain language, context, and the structure and purpose of the statute—including both parties’ positions on those points.

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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. .

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Agency IQ

SEPTEMBER 15, 2023

SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ).

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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

JANUARY 26, 2024

This report yielded some clarification from both industry and the government at the time: According to PhRMA, U.S. This report also refers to an article in the Wall Street Journal indicating that, between 1993 and 1998, the government spent $3.9 PhRMA is unaware of expiration dating for drug products beyond 60 months.”

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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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. CMS will review each complete submission within approximately 30 days of receipt.

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The Pharma Data

DECEMBER 17, 2020

For starters, the findings may not reflect suicides in other states due to differences in race relations, COVID-19 experiences and government responses to the outbreak between the states, he said. The new study does have its share of limitations.

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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

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. government fiscal year runs from October 1 – September 30. As a reminder, the U.S. What’s next? Stay tuned. Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.

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The Pharma Data

FEBRUARY 25, 2022

The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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