FDA’s New Guidance on Real-World Data Spurs Questions from Pharma

Pharma and biotech companies have several questions for the FDA regarding the new guidance documents about real-world data (RWD) that it is currently putting together. For starters, the industry group PhRMA recently pointed out discrepancies between guidance documents, leaving stakeholders scratching their heads. These calls for clarity come as the agency pivots toward greater reliance on RWD for regulatory decisions.

According to Zachary Brennan of Endpoints News, “Incoming FDA chief Rob Califf has been a fan of RWD, particularly when randomized, and has worked on the topic in his previous role at Google’s parent company Alphabet. Life science companies, which previously sought more details on prior guidance docs, are again calling on the FDA to explain itself more.”

Click here to read more.

(Source: Endpoints News, March 7^th, 2022)