FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Treanda Records Subpoenaed

[ Price : $8.95]

A New York U.S. attorney subpoenas records from Cephalon on its Treanda cancer drug.

FDA Accepts Marqibo NDA for Leukemia

[ Price : $8.95]

FDA accepts for filing a Talon Therapeutics NDA seeking accelerated approval for Marqibo (vincristine sulfate liposomes injection)...

FDA Clears Titan Spinal Fusion Device

[ Price : $8.95]

FDA clears a Titan Spine 510(k) for its Endoskeleton TAS system, an anterior lumbar interbody fusion device with integrated fixati...

FDA 'Orphan' Status for PAH Drug

[ Price : $8.95]

FDA grants Tarix Pharmaceuticals orphan drug status for TXA127, the company's lead peptide drug candidate being evaluated for trea...

FDA Approves Calypso IDE for Lung Cancer Study

[ Price : $8.95]

FDA approves a Calypso Medical Technologies IDE for a clinical study evaluating real-time tracking of lung cancer tumors during ra...

AstraZeneca Wants Generic Seroquel Restrictions

[ Price : $8.95]

AstraZeneca petitions FDA to require Seroquel XR ANDA applicants to include labeling covering the risk of hyperglycemia, diabetes,...

Comments Sought on Reprocessed Device Labeling

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information on reprocessed single-use device labeling.

Financial Disclosure Shouldnt Chill Research: PhRMA

[ Price : $8.95]

PhRMA cautions FDA that a new guidance on clinical investigator financial disclosure should not hamper drug research.

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Bionet Co, Dr. Fosters Essentials, Sichuan Pharmaceutical, and Uriel Pharmacy.

Quality Problems Cited in Korean Medical Device Firm

[ Price : $8.95]

FDA warns South Koreans Bionet about Quality System violations in its manufacturing of monitoring and analysis systems.