JD Supra20h
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and effective drugs.
Forbes1y
FDA Report Reveals 300% Increase In Cannabis Research Over The Last Decade—Key Findings
“The FDA believes the drug development and approval process represents the best way to ensure that safe and effective new medicines are available to patients in need of appropriate medical therap ...
JD Supra15d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
The Food and Drug Administration (FDA) has recently released two draft ... its architecture and development process, describing in detail datasets and subsets used in training and tuning including ...
Hosted on MSN29d
19 drug approvals in 2024 that had 'big clinical impact,' according to GoodRx
A DRUG DEVELOPMENT EXPERT SHARES THE PROCESS Earlier this month ... Here is the list in order of FDA approval date. READ ON THE FOX NEWS APP 1. Dupixent – Additional use: Eosinophilic ...
Hosted on MSN1mon
Letters: FDA regulatory process
To achieve that, we should be leading the way on long-overdue reforms at the U.S. Food and Drug ... (FDA). Specifically, when it comes to its goal of balancing reasonable regulation with the ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...
Business Wire16d
Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024
“We are proud that our advanced modeling and simulation software and consulting services supported the development of the majority of drugs approved by the FDA in 2024. This achievement ...
PharmaTimes2d
Cartesian Therapeutics announces FDA agreement for new trial
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...