FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Draft Guide on Blood Pressure Monitoring Sensors

[ Price : $8.95]

FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...

Sato Pharmaceutical FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...

Alert on Compromised Wound/Burn Dressings

[ Price : $8.95]

FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra Life...

Orphan Status for Experimental Myelofibrosis Therapy

[ Price : $8.95]

FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.

Drug Shortage Announcements Can Lead to Protective Purchasing: USP

[ Price : $8.95]

A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...

FDA Push to Move More Drugs to OTC Status

[ Price : $8.95]

FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.

IntraBio Reports Positive Phase 3 Data on Levacetylleucine

[ Price : $8.95]

IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neuro...

Cogent Bio Plans NDA for Bezuclastinib

[ Price : $8.95]

Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...

FDA Soliciting PreCheck Pilot Applications

[ Price : $8.95]

FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufactur...

Support for FDA Biosimilar Comparative Studies Draft Guidance

[ Price : $8.95]

Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...