FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Commissioner Pick Faces Potentially Lengthy Senate Confirmation

[ Price : $8.95]

Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmatio...

Digital Health Technologies Capture Real-Time Info: Column

[ Price : $8.95]

FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally de...

Medline Convenience Kit Recall is Class 1

[ Price : $8.95]

Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components...

4 Observations in Suretec Inspection

[ Price : $8.95]

FDA warns Gilbert, AZ-based Suretec Innovations about CGMP and drug listing violations in its manufacturing of finished drugs.

No Quality Unit Seen in Safrel Pharmaceuticals Inspection

[ Price : $8.95]

FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

FDA Issues Complete Response Letter for Xspray Pharmas Dasynoc

[ Price : $8.95]

FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.

Ultragenyx Gene Therapy OKd for Glycogen Storage Disease

[ Price : $8.95]

FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and child...

Profound Validation Gap in AI Medical Devices: Study

[ Price : $8.95]

Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices ...

FDA OKs Regeneron Therapy for Fibrodysplasia Ossificans Progressiva

[ Price : $8.95]

FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) i...

Draft Guidance on Potency Testing for Active Immunotherapy Products

[ Price : $8.95]

FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, inclu...