FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts Pfizer NDA for Breast Cancer Drug

[ Price : $8.95]

FDA accepts for priority review a Pfizer NDA for palbociclib, intended for use in combination with letrozole as a first-line treat...

FDA Approves VisionCare Telescope for Younger AMD Patients

[ Price : $8.95]

FDA approves a VisionCare Ophthalmic Technologies PMA for its Implantable Miniature Telescope for use in patients living with bila...

Quidel 510(k) for Adenovirus Assay Cleared

[ Price : $8.95]

FDA clears a Quidel Corp. 510(k) to market its Lyra Adenovirus Assay, a real-time polymerase chain reaction test for the qualitati...

Orexo Files sNDA for Zubsolv

[ Price : $8.95]

Orexo AB files a supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) to expand the labeled indication to inclu...

FDA Guidance on Flow Cytometric Devices

[ Price : $8.95]

FDA posts a draft guidance on Flow Cytometric Devices that is intended to address certain issues that arise in premarket submissio...

PhRMA, BIO Attack Exclusivity Guidance for Biological Products

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization say an FDA draft guidance on Refe...

Oregon Compounding Recalls Products Due to Sterility

[ Price : $8.95]

Oregon Compounding Centers recalls certain unexpired human and veterinary sterile products due to a lack of sterility assurance.

FDA Approves Helsinn NDA for Anti-nausea Drug

[ Price : $8.95]

FDA approves a Helsinn Healthcare NDA for Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoin...

Hamburg Announces Key Staff Changes

[ Price : $8.95]

FDA commissioner Margaret Hamburg appoints Denise Esposito from the Office of Chief Counsel as her new chief of staff, and acting ...

FDA, SOCRA Workshop on Clinical Trial Requirements

[ Price : $8.95]

FDA and the Society of Clinical Research Associates plan a Clinical Trial Requirements, Regulations, Compliance, and Good Clinical...