FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Stratus Illegally Marketing Biologics: FDA

[ Price : $8.95]

FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations fro...

FDA Denies 2 Vanda Tasimelteon Petitions

[ Price : $8.95]

FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to ...

FDA Approves Eyelid Mite Disease Drug

[ Price : $8.95]

FDA approves a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an ey...

CDRH Adds Device Sterilization Standards

[ Price : $8.95]

CDRH announces new standards recognized by the agency to improve medical device sterilization.

FDA Expanding CURE ID

[ Price : $8.95]

An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.

Guide on Drug DNA Reactive Impurities

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled M7(R2) Assessment and Control of DNA Reactive (Mutagenic) I...

12 Catalent Inspection Observations

[ Price : $8.95]

FDA releases the form FDA-483 with 12 observations from an inspection at the Bloomington, IN-based Catalent Indiana sterile drug a...

FDA Told: Generally Accepted Often Isnt

[ Price : $8.95]

Three stakeholders raise concerns about an FDA draft guidance on using generally accepted scientific knowledge in drug and biologi...

Meridian Bios H. pylori Test Cleared

[ Price : $8.95]

FDA clears a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori.

Beckman Coulter Chemistry Analyzer Cleared

[ Price : $8.95]

FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medi...