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Guide on Dental Bone Grafting Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Animal Studies for Dental Bone Grafting Material Devices P...

Thoratec Recalls HeartMate Touch Communication

[ Price : $8.95]

Thoratec recalls its HeartMate Touch Communication System due to software design issues.

eSTAR Now Available for Device 513(g) Requests

[ Price : $8.95]

FDA says its electronic Submission Template And Resource system is now available for voluntary 513(g) (device classification) requ...

ProJenX Partial Hold Lifted in ALS Study

[ Price : $8.95]

FDA removes a partial clinical hold against ProJenX and its Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin in ...

Roche Cobas Malaria Test Approved

[ Price : $8.95]

FDA approves Roches cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potentia...

Poll Backs FDA Status Quo in Approving Products

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In the wake of this weeks U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that m...

Guidance on IND Safety Report eSubmissions

[ Price : $8.95]

FDA releases a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports.

Review Extended on Govorestat NDA

[ Price : $8.95]

FDA extends by three months its review of an Applied Therapeutics NDA for govorestat (AT-007) for treating classic galactosemia.

Dental Bone Graft Animal Study Guide

[ Price : $8.95]

FDA publishes a draft guidance to help with animal studies for dental bone grafting devices submitted with a 510(k).

FDA Approves Akebia Vafseo for Some Anemias

[ Price : $8.95]

FDA approves Akeibas Vafseo to treat anemia in some adults with chronic kidney disease.