FDA Law Blog: Biosimilars

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.

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The Pharma Data

NOVEMBER 6, 2020

Learn about new solutions for real-time and thorough monitoring of pharmaceutical water systems to ensure only the highest quality products are delivered to patients. Download Mettler Toledo’s white paper for: Insights on how to meet the demands of ever-stricter water testing regulations head on. Add bookmark.

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The Pharma Data

JANUARY 6, 2021

Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. Download Mettler Toledo’s Pharmaceutical Waters white paper to discover how to: Monitor water for injection in real-time. Add bookmark. Download Your Copy. Ensure water system control.

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Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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The Pharma Data

JANUARY 13, 2021

Download Mettler Toledo’s Pharmaceutical Waters white paper to discover how to: Monitor water for injection in real-time. Ensure water system control. Meet compliance regulations and conductivity measurements. Drive continuous water monitoring in your manufacturing processes.

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PPD

OCTOBER 12, 2023

Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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The Pharma Data

OCTOBER 23, 2020

23, 2020 — In a Society for Healthcare Epidemiology of America white paper, published online Oct. ” Several authors disclosed financial ties to the pharmaceutical and health care industries. Professional. SHEA Updates Guidance for Health Care Staff With Hepatitis, HIV. FRIDAY, Oct. Abstract/Full Text.

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Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

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H1 Blog

NOVEMBER 15, 2023

Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Compliance ensures that interactions between pharmaceutical companies and KOLs are transparent, fair, and free from any undue influence.

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PPD

DECEMBER 19, 2023

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. Read our white paper to learn the keys to successfully implementing functional service partnerships.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Access the white paper The post Patient-Centric Strategies for Successful Oncology Trials appeared first on PPD. Enable every aspect of your complex oncology trial.

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The Pharma Data

MARCH 31, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. About the Janssen Pharmaceutical Companies of Johnson & Johnson. Change Lives. ™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease.

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The Pharma Data

JULY 28, 2021

Teva Pharmaceutical Industries Ltd. On behalf of clients, MGA conducts original data analysis, constructs economic models, conducts research, writes white papers and expert reports and offers strategic advice. Teva saved the United States $28.8 billion in 2020, $4.2 Source link: [link].

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The Pharma Data

NOVEMBER 20, 2020

Agility requires much tighter and more transparent holistic relationships with suppliers and levels of collaboration that have not been consistently achieved in the pharmaceutical industry, largely because of the constraints in sharing accurate data.”.

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The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” Russell served as a director of Endocyte, a Nasdaq-listed public company acquired by Novartis, and AMAG Pharmaceuticals.

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PPD

JULY 9, 2024

How the flex hub model saves one developer time and money As an example of the value that our flex hub model brings to biotech and pharmaceutical developers, here is a brief look at one long-term partnership in place since 2013. Ready to implement an FSP engagement as the ideal solution for all your lifecycle maintenance requirements?

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The Pharma Data

JANUARY 5, 2021

… Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms. Why are Food Studies needed?

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The Pharma Data

JANUARY 6, 2021

… Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are growing at a rate of nearly eight percent annually. . DOWNLOAD TO LEARN MORE>>>> Source link.

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The Pharma Data

DECEMBER 17, 2020

The analysis of metals in pharmaceutical actives (API), raw material, and drug products has changed as well. Today’s technology has not only changed the way we receive information, but has continually adapted and progressed how we acquire information. ICP-MS/OES has emerged as a critical analytical platform for this analysis.

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The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

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The Pharma Data

NOVEMBER 16, 2020

Download Pharma IQ ’s report in collaboration with Dotmatics and BioBright to explore why pharmaceutical data integrity and data security are more important than ever in the life sciences industry. Learn how to improve your data integrity and data security through automation. Download Your Copy.

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The Pharma Data

MARCH 20, 2021

Fermentation is used in the production of renewable feedstocks for food products and ingredients, beverages, pharmaceutical compounds, nutraceuticals, through to fine and bulk chemicals. The Kluyver Center applies microbial genomics to improve the performance of microorganisms in industrial fermentation processes.

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The Pharma Data

MARCH 20, 2021

attention both from the public and the pharmaceutical industry, it is important to recognize concurrent. The lab’s goal is the. use and development of proteomic methods to. study RNA virus replication and virus-host interactions and in particular the use of single-cell proteomics to aid in this research. As the race for an. therapeutics.

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Eye on FDA

NOVEMBER 18, 2021

Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. The reasoning is again based on Dr. Califf’s association with the pharmaceutical industry – an objection that seems less sure-footed this time around.

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FDA Law Blog: Biosimilars

JANUARY 24, 2024

is identified as “Improving Supply Chains for Critical Drugs,” and states: “ In 5 years, deploy broad synthetic biology and biomanufacturing capabilities to produce at least 25% of all active pharmaceutical ingredients (APIs) for small molecule drugs ” (emphasis added). generic pharmaceutical industry, resulting in low profit-margins.

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Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.

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Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. Medicis Pharmaceutical Corp. , vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Paddock Pool Construction Co. , Accord Kreves v.

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