News & Analysis as of

Food and Drug Administration (FDA) › National Evaluation System for Health Technology (NEST)

MoFo Life Sciences

FDA On Use Of AI/ML In Drug Development: Five Key Takeaways

MoFo Life Sciences on

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more

King & Spalding

FDA Announces “Modernization” Reforms to Medical Device Review Process

King & Spalding on

FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process - Last week FDA released two statements announcing plans and...more

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Akin Gump Strauss Hauer & Feld LLP on

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Hogan Lovells

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

Mintz - Health Care Viewpoints

Hospital Adverse Event Reporting System To Be Integrated Into FDA NEST Program

Mintz - Health Care Viewpoints on

Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a...more

Knobbe Martens

FDA Planning Board Emphasizes Use of Data Sharing in Medical Device Monitoring

Knobbe Martens on

The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more

6 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide