FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Accepts Ispen BLA for Dysport in Limb Spasticity

[ Price : $8.95]

FDA accepts for review an Ipsen BLA for Dysport (abobotulinumtoxinA) for use in treating upper limb spasticity in adult patients.

Info on Accredited Persons Inspection Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on the accredited person inspection program to the Office ...

Info on Humanitarian Use Devices to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on humanitarian use devices to the Office of Management ...

Workshop Notice Amended

[ Price : $8.95]

Federal Register Notice: FDA amends a notice of an upcoming public workshop of the Sentinel Initiative.

CDRH Guidance on Natural Rubber Latex Labeling Statements

[ Price : $8.95]

CDRH posts a final guidance on Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container...

FDA Complete Response on Avanir Migraine NDA

[ Price : $8.95]

FDA sends Avanir Pharmaceuticals a complete response letter on its NDA for AVP-825, a drug-device combination of low-dose sumatrip...

FDA Rejects Teva Copaxone Bioequivalence Petition

[ Price : $8.95]

FDA denies a Teva citizen petition that asked the agency to not approve any ANDA for its multiple sclerosis drug Copaxone (glatira...

Since Our Last Issue ...

[ Price : $8.95]

Industry news you may have missed since our last issue.

FDA Denies Most of Risperdal, Invega Petition

[ Price : $8.95]

FDA denies most requests in a petition seeking revocation of the pediatric indication for Risperdal, generic forms of that drug, a...

ConMed Device Correction on Defibrillator Leads

[ Price : $8.95]

ConMed Corp. begins an urgent device correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connec...