Top Takeaways from FDA Final Guidance on Real|World Evidence

How Interested Is The FDA In Real-World Evidence - Clinical Leader

Kaplowitz: The FDA is supportive of observational studies, such as registries, to meet a postmarketing requirement related to safety — when such ...

C3TI Compass (Knowledge Repository) | FDA

Guidance Documents. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and ...

Innovative Medicines Canada (IMC): Final record of decisions May ...

Real world evidence (RWE) for regulatory decision making ... IMC noted that RWE was launched as part of the R2D2 initiative and requested an ...

CY 2025 Medicare Hospital Outpatient Prospective Payment System ...

The final rule advances the agency's commitment to strengthening Medicare and uses the lessons learned from the COVID-19 public health emergency ...

CDC Clinical Practice Guideline for Prescribing Opioids for Pain

CDC developed the guideline using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Recommendations are ...

FDA Guidance on Real-World Evidence, Dr. John Concato - YouTube

... FDA's Real-World Evidence Program, focusing on guidance development. Dr. Concato also summarizes the historical context leading to the ...

National Evaluation System for health Technology (NEST) - FDA

A national evaluation system for health technology will help improve the quality of real-world evidence that health care providers and patients ...

About Handwashing | Clean Hands - CDC

Many diseases and conditions are spread by not washing hands with soap and clean, running water. Handwashing with soap is one of the best ...

What Is Data Mining? How It Works, Benefits, Techniques, and ...

Key Takeaways. Data mining is the process of analyzing a large batch of information to discern trends and patterns. Data mining can be used by corporations ...

A Look at RFK Jr.'s Take on FDA

For example, Kennedy may push the FDA to issue guidance allowing the promotion of “clean foods” using claims that are currently not permitted (e.g., healthier ...

Rare Disease Endpoint Advancement Pilot Program - FDA

For surrogate endpoints, those that use novel approaches for collecting additional clinical data in the pre-market stage to advance the ...

StreetInsider

The world's largest home improvement retailer posted adjusted earnings per... ... Here are the top takeaways from the report:Wider... Trump plans to end EV ...

The Ozempic Effect: Everything You Need to Know About Medical ...

Key Takeaways: · There is a positive impact of Ozempic and similar drugs · Challenges and limitations of medical obesity treatment remain · Bariatric surgery ...

MIT Technology Review

Emerging technology news & insights | AI, Climate Change, BioTech, and more.

Scientists Say Menopause's 'Moment' Is Long Overdue - News

On this episode of Health Science Radio, two leading women's health researchers provide a wide-ranging talk on menopause and possible ...

Fast food effects: Short-term, long-term, physical, mental, and more

Fast food is often nutritionally poor and high in calories. Evidence demonstrates that overeating commercial fast food products can negatively impact health.

Project 2025, Explained | American Civil Liberties Union

A number of its recommendations rely on support from the executive branch and from Congress. Many other initiatives are outright unconstitutional. What Are Some ...

What is "Make America Healthy Again"? What to know about Trump ...

Robert F. Kennedy Jr. has vowed to combat "the chronic disease epidemic in this country" in the Trump administration, with the slogan "Make ...

Leading the Way: New EPA Rule Gives 10 Years to Replace Lead ...

In a White House webinar conducted shortly after the final LCRI was announced, representatives from Denver Water's Lead Reduction Program shared their “lessons ...

FDA, EMA Receive Applications for Subcutaneous Daratumumab in ...

Both applications are supported by data from the phase 3 AQUILA trial (NCT03301220). Initial findings from the study will be presented at the ...