FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accused of Stacking Advisory Panel to Favor Amalgam

[ Price : $8.95]

Again balking at efforts to induce transparency, FDA maintains silence on charges that it has stacked next weeks public advisory p...

Inspection Sees CGMP Problems in Cranial Plate Implant Manufacture

[ Price : $8.95]

FDAs Cincinnati District Office warns OsteoSymbionics about CGMP violations at its cranial plate implant manufacturing facility.

Topaz Nearing NDA for Head Lice Treatment

[ Price : $8.95]

Topaz Pharmaceuticals says it plans a 2011 NDA submission for its ivermectin topical cream as a treatment for head lice.

FDA Releases Report on Graphic Cigarette Labeling

[ Price : $8.95]

Federal Register Notice: FDA adds a research study to the docket proposing required warnings and graphics on cigarette packages.

Comments Sought on Device Registration Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on requirements for additional listing information for medical device registration.

FDA Denies Delmont Labs Hearing on Bacterial Antigens

[ Price : $8.95]

Federal Register Notice: FDA is denying a request by Delmont Labs for a hearing on a proposal to revoke the companys license based...

Sequella Files IND for H.pylori-related ulcers

[ Price : $8.95]

Sequella files an IND with FDA to test SQ109 in patients with H. pylori-related duodenal ulcers.

FDA Accepts sBLA for Subcutaneous Orencia

[ Price : $8.95]

FDA accepts for review a Bristol-Myers Squibb supplemental BLA for a subcutaneous formulation of Orencia (abatacept).

Vivus Plans 2011 NDA for Erectile Dysfunction Drug

[ Price : $8.95]

Vivus says it is planning a second quarter 2011 NDA submission for its erectile dysfunction drug TA-314 (avanafil) after reporting...

Cubist Petition Seeks to Slow Generic Cubicin Approvals

[ Price : $8.95]

Cubist Pharmaceuticals petitions FDA to block approval of generic Cubicin (daptomycin) until potential ANDA submissions meet certa...