Remove Drug Development Remove Medical Records Remove Presentation
article thumbnail

Personalized Medicine Requires a New Approach to Quality Control

Syner-G

Future growth will be driven by factors that include payers mandating the use of such diagnostics, increased understanding of drug safety, advancements in quality of diagnostic testing, and more informed and proactive consumers. Efficient clinical and commercial manufacturing presents issues, too.

article thumbnail

Connecting with Patients at Home

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC).

Hospitals 130
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog: Biosimilars

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

article thumbnail

What is RWE in Pharma?

Viseven

That is why RWE serves many uses and presents many advantages across healthcare ecosystems. Operating with real-world evidence essentially affects the base for medication approvals and drug development acceleration. Why Is Real-World Evidence Important? Big Pharma has already benefited from it.

article thumbnail

How AI, automation, and machine learning are upgrading clinical trials

Pharmaceutical Technology

Artificial intelligence (AI) is set to be the most disruptive emerging technology in drug development in 2023, unlocking advanced analytics, enabling automation, and increasing speed across the clinical trial value chain. Once the trial is launched, you can use AI to do automatic querying and medical coding,” says Clark.

article thumbnail

Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

FDA Law Blog: Biosimilars

The Draft Guidance emphasizes that study team should not answer the questions based on observation or even on existing medical records. Instead, the information should be self-reported or, if that is not possible, provided by a first-degree relative or knowledgeable representative.