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Apotex Recalls Some OTC Ranitidine Tablets

[ Price : $8.95]

FDA announces an Apotex recall of two strengths of generic Zantac labeled for Walgreens, Walmart, and Rite-Aid due to possible NDM...

FDA Guidance on REMS Changes Explained

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

Siemens AI-Rad Chest CT Software Cleared

[ Price : $8.95]

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

FDA Expands Mavyret Indication

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

Device Breakthrough Designation May be Made Public: Shuren

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

Treatment Effects Higher in Accelerated Approvals: Study

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Researchers say the magnitude of treatment effects is higher among drugs and medical devices approved through accelerated pathways...

FDA Renews Certara eCTD Legacy Licenses

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

Atropine Sulfate Not Withdraw Over Safety/Efficacy

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Federal Register notice: FDA determines that Hospiras atropine sulfate ansyr plastic syringe was not withdrawn due to safety or ef...

Regulatory Review Period for MedEl EAS Hearing Device

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

Info Collection Extension on Transplant Tissues

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