FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Sonar Software App Cleared for Respiration Measure

[ Price : $8.95]

FDA clears a Sound Life Sciences 510(k) for its sonar software for consumer smart devices for measuring breathing.

FDA Withdraws 5 No-Longer Marketed ANDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants because they are no longer marketed.

Merck sBLA for Pneumococcal Vaccine

[ Price : $8.95]

FDA accepts for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive...

Complete Response Letter for Plinabulin

[ Price : $8.95]

FDA tells BeyondSpring Pharmaceuticals a second study is needed to demonstrate substantial benefit of its plinabulin in preventing...

Class 2 for Isocapnic Ventilation Devices

[ Price : $8.95]

Federal Register notice: FDA classifies isocapnic ventilation devices into Class 2 (special controls), following a de novo classif...

Info Collection on Investigator Financial Disclosures

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Inves...

FDA Patient Engagement Panel Renewal

[ Price : $8.95]

Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expir...

FDA Approves Darzalex Faspro for Myeloma

[ Price : $8.95]

FDA approves Janssens Darzalex Faspro plus Kyprolis and dexamethasone to treat some multiple myelomas.

GDUFA Science and Research Priority Initiatives

[ Price : $8.95]

FDA publishes 15 GDUFA scientific and research priorities for FY 2022.

CTI BioPharma Myelofibrosis NDA Review Extended

[ Price : $8.95]

FDA extends by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary o...