The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.
Advancing the development of interchangeable biosimilars and reducing or developing alternatives to clinical studies involving human subjects have been highlighted as the key priorities for a US Food and Drug Administration regulatory science pilot program under the third iteration of the Biosimilar User Fee Amendments, in a detailed new document released by the agency.
In the “Research Roadmap” document that has just been published by the FDA, the agency sets out in more...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
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Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
Emerging CRISPR innovations, shifting regulatory landscapes, and rising partnerships are accelerating a paradigm shift in biotech pipelines
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.
