How real-world evidence can directly support innovation

Turning clinical observations into real-world evidence (RWE) is influencing how therapies are validated and brought to patients.
National Academies of Sciences%2c Engineering%2c and Medicine

Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings of a Workshop

Suggested Citation: "3 Opportunities for Real-World Data." National Academies of Sciences, Engineering, and Medicine. 2017. Real-World Evidence Generation and Evaluation of Therapeutics: Proceedings ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
FierceBiotech

How AI and real-world evidence are powering smarter decisions across the drug and device development lifecycle

Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data. Yet it can be ...
Medscape

Europe Promotes Real-World Data to Improve Drug Regulation

The European Medicines Agency (EMA) uses Data Analysis and Real-World Interrogation Network (DARWIN EU), a data network that became fully operational in 2024, to generate real-world evidence on ...
The American Journal of Managed Care

Real-World Evidence Standards Bridge Research, Clinical Decision-Making: Cate Lockhart, PharmD, PhD

Real-world evidence helps pharmaceutical companies and payers communicate more effectively. In this Q&A, Cate Lockhart, PharmD, PhD, chief science officer of the Academy of Managed Care Pharmacy (AMCP ...
Forbes

Inside The Race To Harness Real-World Data: Who Will Build Healthcare’s Most Powerful Platform?

In the late 1800s, the U.S. railroad system didn’t just revolutionize transportation—it catalyzed entirely new industries. Refrigerated railcars enabled a national meatpacking economy. Standard time ...
FiercePharma

What Does Clinical Trial Tokenization Mean for Real-World Data and Long-Term Patient Follow-Up?

Why is tokenization important for the future of medicine development? A tremendous amount of data is collected throughout a clinical trial, but prior to tokenization, the life science industry did not ...
USA Today

MEDDDICAL Launches Real-World Evidence Strategy & Analytics For Pharma & MedTech

MEDDDICAL has launched a real-world evidence analytics and advisory service, offering structured guidance to pharmaceutical and MedTech companies at a time when real-world evidence requirements from ...
Hosted on MSN

FDA making use of real-world evidence in device applications easier

The US FDA will no longer require that identifiable individual patient data be required from applicants when submitting real-world evidence as part of certain medical device applications. Sponsors ...
JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...
Fox Business

FDA rolls back 'red tape' in move aligned with Trump push to speed up new cures

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...