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FDA Clears Kator Suture Anchor System

[ Price : $8.95]

FDA clears a Kator 510(k) for the Kator Suture Anchor System for use in tissue-to-bone reattachment.

FDA Approves Perrigo ANDA for Generic KlorCon

[ Price : $8.95]

FDA approves a Perrigo ANDA for a generic version of Upsher-Smith Laboratories KlorCon (potassium chloride) extended-release table...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biomedic Labs Johnson Memorial Cancer Center, and Orgen Nutraceuticals.

Senate Hearing on Califfs Nomination Set for 11/17

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The Senate Health, Education, Labor and Pensions Committee sets an 11/17 hearing to review the nomination of FDA deputy commission...

Dr. Reddys Needs Third-party Auditor, CEO Says

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Dr. Reddys Laboratories says FDA has directed it to hire a third-party auditor to evaluate its three Indian manufacturing plants t...

FDA Hits LDT Firms for DTC Tests Without Clearance

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FDA sends three laboratory-developed test makers letters challenging their genetic tests being marketed to consumers without agenc...

FDA Breakthrough Status for Tevas SD-809

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FDA grants Teva Pharmaceutical Industries a breakthrough therapy designation for SD-809 (deutetrabenazine) for treating patients w...

FDA Grants Collegium Tentative Approval on Pain Drug

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FDA grants Collegium Pharmaceutical tentative approval for its NDA for Xtampza ER (oxycodone) extended-release capsules for managi...

Purdue Petition Seeking Delay on Pfizer Pain Drug Denied

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FDA denies without comment a petition from Purdue Pharma that sought an order from FDA to require a Pfizer 505(b)(2) NDA for pain ...

FDA Clears EDAP Ablatherm HIFU for Prostate Tissue

[ Price : $8.95]

FDA clears an EDAP TMS 510(k) to market its Ablatherm Integrated Imaging HIFU (High intensity focused ultrasound) for ablating pro...