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.
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? ”.
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PPD
OCTOBER 12, 2023
There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.
The Pharma Data
SEPTEMBER 11, 2020
Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinical development efforts now and in the future.”.
PerkinElmer
FEBRUARY 18, 2021
Dr. Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer White Paper offers a detailed look at the findings.
Agency IQ
APRIL 12, 2024
ACRO’s white paper also highlights the potential for “enhanced efficiency, long-term cost savings, and faster collection of data” through risk-based monitoring and other data collection efficiencies. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA’s regulation.”
PPD
DECEMBER 19, 2023
As biotech and biopharma companies seek out the best solutions in increasingly competitive talent markets – and adapt to new demands, priorities and challenges – it’s important to remember that not all FSP/FSO providers are alike. Ready to fuel more efficient drug development?
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