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.

Packaging 40

Packaging Government Production 40

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.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

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.

Packaging 40

Packaging Regulations Production Compliance 40

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.

Science 130

Science Drugs Pharmaceutical Companies Pharmaceuticals 130

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

Nurses 52

Nurses Packaging Government Doctors 52

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.

Packaging 40

Packaging Regulations Government Production 40

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?

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

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.

FDA Approval 52

FDA Approval Vaccine FDA Treatment 52

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.

FDA 40

FDA Government Packaging Production 40

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.

Production 52

Production Packaging Government 52

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.

Licensing 59

Licensing Licensing Production Marketing 59

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.

Biosimilars 59

Biosimilars FDA Production Packaging 59

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. .

Vaccine 52

Vaccine Pharmacy Packaging Production 52

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.

Vaccine 52

Vaccine Virus Clinical Trials Government 52

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.

Vaccine 52

Vaccine Virus Immune Response Government 52

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.

Vaccine 52

Vaccine Virus Immune Response Government 52

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.

Regulations 52

Regulations FDA Packaging Clinical Trials 52

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.

Government 52

Government Packaging Research Treatment 52

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.

Regulations 40

Regulations International Government Compliance 40

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.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

Therapies 59

Therapies FDA Production Regulations 59

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.

Engineering 40

Engineering Packaging International Production 40

Agency IQ

AUGUST 18, 2023

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. varies based on government agency. European Union The E.U. Currently, the CLP is aligned with parts from the sixth and seventh revised editions of the GHS.

International 40

International Regulations Packaging Animal Testing 40

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.

Regulations 40

Regulations Animal Testing Production Marketing 40

The Pharma Data

JANUARY 13, 2021

These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), (..)

Clinical Trials 52

Clinical Trials FDA Trials Production 52

Perficient: Drug Development

FEBRUARY 28, 2024

Feature tables package their own data sources. Feature metadata is packaged with models that are trained using features from the Databricks Feature Store. Unity Catalog Unity Catalog is the unified governance layer for the Databricks Intelligence Platform. This package is pre-installed on Databricks Runtime 13.2

Engineering 69

Engineering Packaging Government 69

The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (“FDA”) will grant an Emergency Use Authorization (“EUA”) for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such (..)

Hospitals 52

Hospitals Trials Clinical Trials Production 52

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. as well as other studies or inspections under the Food Safety Modernization Act (FSMA).

FDA 40

FDA Regulations Packaging Marketing 40

Agency IQ

JUNE 17, 2024

Likewise, the Biocidal Products Regulation (BPV), Switzerland’s principal rules governing biocides, has been largely harmonized with the bloc’s Regulation (EU) 528/2012 on biocidal products (BPR). The basis of national chemicals legislation in Switzerland is the Chemicals Act (ChemG) and the Environmental Protection Act (USG).

Regulations 40

Regulations Production International Packaging 40

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)

Government 52

Government Vaccine Production Licensing 52

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.

Vaccine 52

Vaccine Virus Trials Hospitals 52

The Pharma Data

JANUARY 25, 2021

Additional directives will foster research into new treatments for COVID-19, strengthen the collection and analysis of data to shape the government’s pandemic strategy; and direct the federal occupational safety agency to release and enforce guidelines to protect workers from getting infected, the Post reported. .

Vaccine 52

Vaccine Packaging Government International 52

The Pharma Data

JANUARY 16, 2021

trillion pandemic “rescue” package that includes $20 billion for the vaccine effort. That number is likely to jump quickly now that the federal government has given states the OK to vaccinate anyone over 65 and said it would release all the doses of vaccine it has available for distribution.

Vaccine 52

Vaccine Nurses Virus Hospitals 52

Agency IQ

JUNE 28, 2024

These state-level legislative actions all front-run the federal government, which has not yet passed any far-reaching laws focused on curbing the use of PFAS in products or other areas. Case study: Maine In July 2021, the Maine legislature passed LD 1503, An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution.

Production 40

Production Regulations Compliance Packaging 40

The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration (“FDA”) with respect to a potential Emergency Use Authorization (“EUA”) for REGN-COV2, and possible regulatory approval of REGN-COV2; whether the FDA will grant an EUA for REGN-COV2 and, if an EUA is granted, the scope and terms of such EUA and how long such EUA would remain in effect for REGN-COV2; (..)

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. The PDUFA VII Commitment Letter describes the agreed-upon standard review times for most drug products.

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

NOVEMBER 20, 2023

Sentinel is governed by three centers: the Sentinel Operations Center, led by Harvard Pilgrim Health Care institute; the Sentinel Innovation Center; led by Harvard Medical School; and the Community Building and Outreach Center, led by Deloitte. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

Science 40

Science FDA Regulations Research 40