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Companies Recall Ranitidine, Nizatidine

[ Price : $8.95]

FDA says Appco and Northwind have recalled ranitidine and Mylan has recalled nizatidine due to potential NDMA contamination.

Regeneron Sees Encouraging Garetosmab Results in FOP

[ Price : $8.95]

Regeneron reports positive results from the LUMINA-1 trial of its garetosmab in treating fibrodysplasia ossificans progressiva.

FDA MyStudies Platform on Google Cloud

[ Price : $8.95]

Health IT News reports that Google is making the FDA MyStudies open-source platform available on Google Cloud.

Blueprint Medicines GIST Drug Approved

[ Price : $8.95]

FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating certain adults with unresectable or metastatic gastr...

FDA Withdrawing 249 ANDAs Over Annual Reports

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Federal Register notice: FDA proposes to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly faile...

Info Collection on Tissue Transplantation

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Federal Register notice: FDA submits to OMB an information collection extension for Human Tissue Intended for Transplantation 21 ...

Ways to Overcome Drug Company Regulatory System Abuse

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Researchers suggest ways Congress could clamp down on abuses of FDA regulatory processes that drug companies use to delay generic ...

FDA Part of Unified Web Site for Biotechnology Regulation

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FDA, the Agriculture Department, and EPA launch a unified Web site for biotechnology regulation.

New CDRH Tool for Scope Reprocessing Assurance

[ Price : $8.95]

CDRH scientists and engineers develop a new tool to help hospitals determine how clean an endoscope is after it has been reprocess...

Info Collection on Administrative Practice/Procedures

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Federal Register notice: FDA seeks comments on an information collection revision for General Administrative Practice and Procedur...