FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Aqualex FDA-483 Has 6 Inspection Observations

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from a 2023 inspection at the Republic of Koreas Aqualex cosmetic and drug man...

Trial Planned for New Weight Loss Drug

[ Price : $8.95]

FDA accepts an Antag Therapeutics IND for its lead molecule, AT-7687, to begin a Phase 1 clinical trial to evaluate it for treatin...

CDRH Prioritized FY 2024 Guidance List

[ Price : $8.95]

CDRH posts a list of final and draft guidances it expects to publish in FY 2024.

FDA Plans Pediatric Acetaminophen Safety Order

[ Price : $8.95]

While denying a Parenteral Technologies petition to force a change in pediatric acetaminophen directions for use, FDA says it is p...

Medical Device Company Sentenced to Pay $42 Million

[ Price : $8.95]

The Justice Department says Magellan Diagnostics has been ordered to pay $42 million in fines, forfeitures, and compensation after...

FDA Approves Genentechs Itovebi Breast Cancer Drug

[ Price : $8.95]

FDA approves Genentechs Itovebi to be used with two other drugs to treat some breast cancers identified through a diagnostic test....

Implantable Bladder Stimulator Study Approved

[ Price : $8.95]

FDA approves an IDE for Iota Biosciences to conduct a feasibility study of its investigational implantable device designed to deli...

Part 11 Final Guide has Broader Applicability: Attorneys

[ Price : $8.95]

Attorneys at Hogan Lovells say (XXX DELETE s XXX)that a final guidance on electronic records and systems used in clinical trials i...

Teva Pays $450 Million to Settle Kickback Cases

[ Price : $8.95]

Teva Pharmaceuticals agrees to pay $450 million to resolve two civil cases that allege the company violated the Anti-Kickback Stat...

Zyno Medical Recalls Z-800 Infusion Devices

[ Price : $8.95]

Zyno Medical recalls (Class 1 device correction) various models of its Z-800 Infusion System due to a defect in the air in-line so...