FDA Law Blog: Biosimilars
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.
Advarra
MAY 26, 2023
The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.
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Conversations in Drug Development Trends
MARCH 7, 2024
Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.
Conversations in Drug Development Trends
MARCH 20, 2024
To learn more about these various genes and how they can affect your clinical trial participants, as well as to understand the full extent of the power of pharmacogenomics, check out our white paper. The post How Pharmacogenomics Can Benefit Your Clinical Trial appeared first on Worldwide Clinical Trials.
PPD
OCTOBER 12, 2023
In this uncharted landscape, it is critical that clinical trial teams possess familiarity with past regulatory guidance as well as new technologies and methods for reducing regulatory risks. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.
PerkinElmer
FEBRUARY 18, 2021
A PerkinElmer White Paper offers a detailed look at the findings. Top 10 trends in pre-clinical drug discovery at top 20 Pharma 1. These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Oncology is the top therapeutic area of interest, today and tomorrow.
PPD
MARCH 21, 2024
A Wealth of Pediatric Clinical Trial Experience When enacting strategies to tailor pediatric clinical trials to the child’s needs, experience matters. The PPD clinical research business of Thermo Fisher Scientific has demonstrated its expertise in taking extraordinary measures to improve the lives of pediatric patients.
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