World Evidence Program News Today

Advanced preparations for potential commercial launch of BT-001 in U.S. in mid-2023 Reported positive topline results from exploratory trial for fatty liver disease Announced restructuring and... | March 30, 2023

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the...

/PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of a paper entitled, "Intravenous edaravone treatment in ALS and...

Pfizer Inc. today announced overall survival results from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE® in combination with letrozole compared to placebo plus letrozole for the... | June 4, 2022

Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA...

Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA...

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including…

Earlier this week, the Food and Drug Administration released the latest in a series of draft guidance documents on the topic of real-world data (RWD) to support regulatory decision-making for drugs...

Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a...

Decentralized clinical trials have increased in response to the COVID-19 pandemic, yet this may be due to a convergence of two factors already in...