FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Canon Optical Coherence Tomography Cleared

[ Price : $8.95]

FDA clears a Canon 510(k) for its Xephilio OCT-A1 Optical Coherence Tomography device for in-vivo imaging and measurement of the r...

First Project Orbis Action with Australia, Canada

[ Price : $8.95]

FDA, Australia, and Canada collaborate for the first Project Orbis simultaneous drug approval for Lenvima and Keytruda to treat a ...

Five OPDP Research Studies Awaiting Publication

[ Price : $8.95]

The Coalition for Healthcare Communication reports that five research studies conducted by CDERs Office of Prescription Drug Promo...

Changes Sought in FDA Pharmacokinetics Guidance

[ Price : $8.95]

Five stakeholders recommend changes to an FDA draft guidance on population pharmacokinetics.

Latest FDA Warning Letters

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes Deb USA and 21st Century Scientific.

Gottlieb Joins Aetions Board of Directors

[ Price : $8.95]

Former FDA commissioner Scott Gottlieb joins Aetions board of directors.

New FDA KASA System Explained

[ Price : $8.95]

Six CDER staffers explain the new FDA Knowledge-aided Assessment & Structured Application system being developed and implemented t...

Takeda Recalls Natpara Over Rubber Particulates

[ Price : $8.95]

Takeda Pharmaceutical Co. recalls all doses of Natpara (parathyroid hormone) for injection due to a potential issue related to rub...

Panel on Cybersecurity Communications Standards

[ Price : $8.95]

An FDA advisory committee recommends that FDA should develop standards for device companies to use when any cybersecurity concern ...

53 Product-Specific Guidances for ANDAs

[ Price : $8.95]

Federal Register notice: FDA makes available 53 product-specific guidances (PSGs) 34 new guidances and 19 revised ones.