FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Novelos Therapeutics Has New Imaging Agent

[ Price : $8.95]

Novelos Therapeutics says it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative...

Effient Not Superior to Clopidogrel: Researchers

[ Price : $8.95]

In a head-to-head trial, researchers say they did not find Eli Lilly blood-thinning drug Effient (prasugrel) to be superior to San...

FDA Allows Caraco to Resume Producing 2 Products

[ Price : $8.95]

FDA authorizes Caraco to resume production of two drug products at its Michigan facilities.

FDA Implements Misconduct Records System

[ Price : $8.95]

Federal Register Direct final rule: FDA implements a new systems of records on research misconduct proceedings.

Review Period Set for Torisel

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Wyeths Torisel for the purpose of patent extension.

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Alfa Vitamins Laboratories, Dragon Herbs, Healing Ways, and HSAC Enterprises, In...

FDA Cites Hospira Over Infusion Pump Manufacturing

[ Price : $8.95]

FDA cites Hospira over GMP deficiencies related to infusion pumps manufactured at the firms La Aurora de Heredia, Costa Rica facil...

Genentech Files BLA for Trastuzumab Emtansine for Breast Cancer

[ Price : $8.95]

Genentech files a BLA for trastuzumab emtansine, seeking approval to treat people with HER2-positive metastatic breast cancer.

Q&A Guidance on Generic Drug User Fee Amendments

[ Price : $8.95]

FDA posts a draft guidance on questions and answers related to generic drug user fees.

FDA Not Concerned About DepoCyte After EU Recall

[ Price : $8.95]

CDER officials say they are not too concerned with European inspection findings and a subsequent recall involving Pacira Pharmaceu...