FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Rocket Medical Has Quality Issues

[ Price : $8.95]

FDA warns Britains Rocket Medical about Quality System violations in its manufacturing of IVF devices.

OraWell Selling Unapproved Test Kit

[ Price : $8.95]

FDAs Philadelphia District Office warns OraWell USA about manufacturing an HIV test kit without premarket approval or an IDE.

FDA Clears Accuray Dose Control System

[ Price : $8.95]

FDA clears an Accuray 510(k) for the Dose Control System (DCS), a new feature for the company's TomoTherapy Radiation System to im...

Groups Give Feedback on PDUFA Proposal

[ Price : $8.95]

Industry and patient/consumer groups provide feedback to FDA on the negotiated Prescription Drug User Fee Act reauthorization prop...

Pixantrone NDA Resubmitted

[ Price : $8.95]

Cell Therapeutics resubmits its pixantrone NDA to FDA, responding to a complete response letter and recommendations from the CDER ...

Lilly Yanks Xigris Due to Low Benefit-Risk

[ Price : $8.95]

Eli Lilly withdraws its sepsis drug Xigris (drotrecogin alfa activated) after clinical trial results from a study called PROWESS-...

FDA Questions Medtronic Ablation System Safety

[ Price : $8.95]

CDRH asks the Circulatory System Devices Panel for input on the safety of Medtronics Cardiac Ablation System for which the company...

Groups Want Physician Payment Sunshine Implemented

[ Price : $8.95]

Seven organizations ask HHS to move quickly to implement the Physician Payments Sunshine provision of the healthcare reform law.

Guidance for Cigarette Package Warning Requirements

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Required Warnings for Cigarette Packages and Advertisements Small Entity Compli...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Health Advances USA, Measurement Specialties, OraWell USA, and Rocket Medical.