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Abbott Patient Controller Approved on iPhone

[ Price : $8.95]

FDA approves an Abbott PMA to allow use of the companys Patient Controller app on compatible personal Apple smartphone devices.

Jazz NDA for Daytime Sleepiness Approved

[ Price : $8.95]

FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating ...

FDA Drug Development Tool Qualification Stats

[ Price : $8.95]

FDA publishes six-month summary statistics for drug development tool qualification projects.

FDA Wants Doctors to Discuss Naloxone with Patients

[ Price : $8.95]

FDA says healthcare professionals should discuss naloxone with patients taking opioid pain medicines or drugs for opioid use disor...

Fresenius Recalls 2 Lots Dexmedetomidine

[ Price : $8.95]

Fresenius Kabi recalls two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount ...

FDA Warns Clinics on Unapproved Covid Cures

[ Price : $8.95]

FDA and the Federal Trade Commission says Create Wellness Clinics is marketing several types of unapproved products intended to tr...

Many Recalls in Healthcare Deployment of Devices: Report

[ Price : $8.95]

Internet of Things (IoT) security firm Ordr says many IoT medical devices have been subject to FDA recall as defective or risky.

Senate Bill on FDA Seizing/Detroying Counterfeit Devices

[ Price : $8.95]

U.S. senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) introduce legislation that would help protect patients from counterfeit me...

More Class 2 Devices Exempt from 510(k)

[ Price : $8.95]

Federal Register notice: FDA publishes an order to exempt a list of Class 2 devices from 510(k) requirements, subject to certain l...

Guide on Human Cell Tissue Products

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cel...