FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Sunovian NDA for New Chemical Entity in ADHD

[ Price : $8.95]

Sunovion Pharmaceuticals files an NDA for dasotraline, an investigational, dual-acting dopamine and norepinephrine reuptake inhibi...

CDER, ORA Concept of Operations Being Implemented

[ Price : $8.95]

FDA commissioner Scott Gottlieb says a new concept of operations for CDER and ORA is being implemented to integrate drug facility ...

Hospira Recalls Vancomycin Lot for Particulate Matter

[ Price : $8.95]

Hospira recalls one lot of vancomycin hydrochloride after confirming a report of glass particulate in one vial in the lot.

FDA Updates MedDra Medical Dictionary Recognition

[ Price : $8.95]

Federal Register notice: FDA announces support for the most current version of the Medical Dictionary for Regulatory Activities, a...

Cenestin Not Withdrawn Over Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that Tevas Cenestin (estrogens, conjugated synthetic A) tablets, 0.3 milligrams (mg), 0.45...

Spectranetics Recalls Bridge Occlusion Balloon

[ Price : $8.95]

Spectranetics recalls its Bridge Occlusion Balloon due to the potential for a blocked guidewire lumen.

SteadyMed Gets Refuse-to-File Letter on Trevyent

[ Price : $8.95]

FDA issues SteadyMed Ltd. a Refuse-to-File letter on its NDA for Trevyent (treprostinil) for treating pulmonary arterial hypertens...

Lilly, Incyte to Refile Baricitinib NDA

[ Price : $8.95]

Lilly and Incyte says they will resubmit their baricitinib NDA by the end of next January.

FDA Approves Tevas Austedo for Tardive Dyskinesia

[ Price : $8.95]

FDA approves a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating tardive dyskinesia in adults...

Guidance on Real-World Evidence in Device Decisions

[ Price : $8.95]

FDA says it will issue a guidance on how it evaluates real-world evidence in medical device regulatory decisions.