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Boston Scientific Brain Stimulator Programming Software OKd

[ Price : $8.95]

FDA approves a Boston Scientific PMA for its latest image guided programming software, Vercise Neural Navigator with StimViewXT, f...

Three ICH Guidelines Reach Stage 2

[ Price : $8.95]

The International Council on Harmonization says three guidelines are at Stage 2 and open for public comment.

Apply for Naloxone OTC: Lawmakers

[ Price : $8.95]

Some 30 House and Senate members ask CEOs of seven manufacturers of naloxone to seek OTC status for their drug.

FDA Convening Panel on Virtual Reality Devices

[ Price : $8.95]

FDA announces a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented...

Multiple Violations at Generitech

[ Price : $8.95]

FDA warns Fresno, CA-based Generitech Corp. about multiple repeat violations in its production of finished drugs.

Otect Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Clinigens Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to sa...

Repeat Violations at 3 Ultra Seal Facilities

[ Price : $8.95]

FDA warns New Paltz-NY headquartered Ultra Seal Corp. about CGMP violations at its headquarters and two other drug manufacturing f...

FDA Finds Repeat Violations at Yusef Labs

[ Price : $8.95]

FDA warns Clearfield, UT-based Yusef Manufacturing Laboratories about multiple repeated CGMP violations in its production of finis...

Veru Reports Positive Data from Covid Therapy Trial

[ Price : $8.95]

Veru Inc. announces positive efficacy and safety results from an interim analysis of a Phase 3 Covid-19 clinical trial evaluating ...

2 Performance Based Pathway Guidances

[ Price : $8.95]

FDA publishes two guidances giving submitters using the 510(k) Safety and Performance Based Pathway for two specific products an o...