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Human Drugs

FDA Guidance on REMS Changes Explained

Three Drinker Biddle attorneys caution drug companies to consult a recent FDA final guidance on REMS modifications and revisions to be sure distributi...

Medical Devices

Siemens AI-Rad Chest CT Software Cleared

FDA clears a Siemens Healthineers 510(k) for three modules of its AI-Rad Companion Chest CT, a software assistant that brings artificial intelligence ...

Human Drugs

FDA Expands Mavyret Indication

FDA approves an expanded indication for AbbVies hepatitis C drug Mavyret.

Medical Devices

Device Breakthrough Designation May be Made Public: Shuren

CDRH director Jeffrey Shuren says FDA would like to hear from companies if they would be comfortable having the agency make medical device breakthroug...

Medical Devices

Abbott Recharge-Free Neurostimulation Device OKd

FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.

Treatment Effects Higher in Accelerated Approvals: Study

Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways than in those for w...

Human Drugs

FDA Renews Certara eCTD Legacy Licenses

FDA renews Certaras legacy licenses for its GlobalSubmit drug and biologics review software for another year.

Federal Register

Atropine Sulfate Not Withdraw Over Safety/Efficacy

Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or effectiveness reasons....

Federal Register

Regulatory Review Period for MedEl EAS Hearing Device

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Med-El Electromedizinische Gerates medical devi...

Federal Register

Info Collection Extension on Transplant Tissues

Federal Register notice: FDA seeks comments on an information collection extension for Human Tissue Intended for Transplantation 21 CFR Part 1270.