FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Drug Promotion Research Landscape Analyzed

[ Price : $8.95]

FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas...

Brainomix AI Stroke Tool Cleared by FDA

[ Price : $8.95]

FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.

Viz.ai Algorithm Cleared for Abdominal Aneurysms

[ Price : $8.95]

FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic ane...

Regulatory Review Period for Esperoct

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Esperoct (ant...

Device Regs Amended to Correct Errors

[ Price : $8.95]

Federal Register notice: FDA amends certain medical device regulations to update mailing addresses and docket numbers.

Sandoz sBLA for Citrate-free Hyrimoz

[ Price : $8.95]

FDA approves a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvies Humir...

ICH Approves Gene Therapy S12 Guidance

[ Price : $8.95]

The International Council for Harmonization approves the S12 guidance on nonclinical biodistribution studies for gene therapy prod...

Changes Suggested for Cancer Drug Dosing Guidance

[ Price : $8.95]

The Friends of Cancer Research suggests possible additions to an FDA draft guidance on optimizing the dosage of oncologic drugs.

Significant CGMP Violations at Dunagin Pharmaceuticals

[ Price : $8.95]

FDA warns Rogers, AR-based Dunagin Pharmaceuticals, which does business as Massco Dental, about CGMP violations in its manufacturi...

Multiple Violations at Contract Manufacturer

[ Price : $8.95]

FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as ...