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Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.
With so many companies developing treatments and vaccines against coronavirus, and most other affected by the pandemic, they can’t all be winners.
The pharma, biotech and allied industries came together in London on 4 December to celebrate another year of achievement at the 15th Annual Scrip Awards, hosted by the broadcaster Fiona Bruce.
Feedback on application-specific data submission issues that vexed the agency but were not onerous enough to warrant a refuse-to-file letter would help inform future filings and reduce variation across sponsors, industry representatives say at meeting on analytical data standards.
- Contract Research, Toxicology Testing-CRO