FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Regulatory Review Period for Caplyta

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Intra-Cellular Therapies Ca...

Advisors to Discuss Pulse Oximeter Accuracy

[ Price : $8.95]

FDA says the Anesthesiology and Respiratory Therapy Devices Panel will meet virtually on 11/1 to discuss issues of potential pulse...

Elemental Impurities Guidance

[ Price : $8.95]

FDA publishes an International Conference on Harmonization revised guidance on elemental impurities in drug products.

Tavalisses Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rigel Pharmaceuticals Taval...

FDA Investigators Target Pharmaceutical Water Systems

[ Price : $8.95]

CDER Office of Manufacturing Quality director Francis Godwin warns that FDA investigators are paying close attention to pharmaceut...

FDA Approves Mallinckrodt Kidney Drug

[ Price : $8.95]

FDA approves Mallinckrodts Terlivaz (terlipressin) injection for improving kidney function in certain adults with hepatorenal synd...

FDA Rejects Hearing Aid Standardization

[ Price : $8.95]

FDA denies a petition asking it to standardize hearing aid features in new over-the-counter hearing aids and rate them.

FDA Partnership on Rare Neurodegenerative Diseases

[ Price : $8.95]

FDA joins the National Institutes of Health in launching a Critical Path for Rare Neurodegenerative Diseases public-private partne...

FDA Determines Review Period for Migraine Drug

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys migraine drug Re...

Bob Temple Gets New Title, Role Remains the Same

[ Price : $8.95]

CDER director Patrizia Cavazzoni removes Bob Temples deputy Center director title and renames him senior advisor for clinical scie...