FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Updates AI/ML-Enabled Medical Device List

[ Price : $8.95]

FDA adds 171 devices to its list of AI/ML-enabled medical devices.

Untitled Letter for Indias Nectar Lifesciences

[ Price : $8.95]

FDA cautions Indias Nectar Lifesciences about CGMP violations in its production of finished drugs.

Guide on Drug, Biologic Benefit/Risk Assessment

[ Price : $8.95]

FDA publishes a guidance on considerations about a drugs benefits and risks that the agency applies to certain premarket and postm...

SeaStar Breakthrough Status for Cytopheretic Device

[ Price : $8.95]

FDA grants SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device for use i...

Hamilton Medical Ventilators Recalled

[ Price : $8.95]

Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventil...

Courts Could Cut FDA Labeling Enforcement: Avorn

[ Price : $8.95]

Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA...

FCA Cases Look at Cybersecurity: Attorneys

[ Price : $8.95]

Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufac...

BrainStorm Pulls NurOwn BLA

[ Price : $8.95]

BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path...

FDA Posts 6 Approved Info Collections

[ Price : $8.95]

Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.

Naropin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safet...