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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
JD Supra14d
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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
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.
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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 ...
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 ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
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FDA Grants FTD to 64Cu-SAR-bisPSMA for PET Imaging in Prostate Cancer
The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...
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 ...
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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 ...