Brexit - What will the impact be?
With less than 100 days to go to Brexit what should the UK Pharmaceutical industry expect?
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CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
New platform will employ machine learning to provide clinical trial sponsors with crucial insights to model feasibility scenarios in seconds
The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption.
Citeline Study Feasibility
This informative whitepaper introduces you to best practices in study feasibility, which laid the groundwork for our new predictive analytic that is launching soon, Citeline Study Feasibility. Our industry-leading technology will deliver advanced insight to improve your clinical trial decisions, fast-track enrollment and optimize cycle times – all with less effort.
Topic Clinical Trials
Arriving two to three months later than planned, Novavax’s nanoparticle-based vaccine is still a welcome addition to the field, for both rich and poor countries.
In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.
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