FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Lifts Hold on Spero Antibacterial Trial

[ Price : $8.95]

FDA removes a Spero Therapeutics clinical hold on a Phase 2 trial of SPR720, an investigational oral product being developed for n...

FDA Postpones Inspections as Omicron Spreads

[ Price : $8.95]

FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for mission-critical inspecti...

Ideal Pharmacy Inspection Observations

[ Price : $8.95]

FDA releases an FDA-483 with seven observations from an inspection at Union, NJ-based Ideal Pharmacy.

FDA Chief Scientist Office Organization Structure Modified

[ Price : $8.95]

Federal Register notice: FDA announces that its Office of the Chief Scientist has modified its organizational structure.

Allowable Excess Volume/Content MAPP

[ Price : $8.95]

The CDER Office of Pharmaceutical Quality issues a MAPP for its product quality assessors on consistent assessment of excess volum...

Politics Shouldnt Block Califf: Column

[ Price : $8.95]

Columbia University College of Physicians and Surgeons psychiatry chair Jeffrey Lieberman makes the case for Robert Califf to retu...

Lessons from FDA Aseptic Mfg. Inspections

[ Price : $8.95]

FDAer Brooke Higgins discusses aseptic processing issues at a PDA/FDA joint regulatory conference.

FDA Will Review sBLA for Humira Biosimilar

[ Price : $8.95]

FDA accepts for review a Samsung Bioepis sBLA for a high-concentration Humira biosimilar.

Helios Cardios CardiaMend Cleared by FDA

[ Price : $8.95]

FDA clears a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, indicated for both pericardial ...

Info Collection on Drug Compounding Facilities

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information To Understand Challen...