FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

House Committees Expand Emergent BioSolutions Probe

[ Price : $8.95]

The House Committee on Oversight and Select Subcommittee on the Coronavirus Crisis ask AstraZeneca and J&J for detailed informatio...

FDA Plans Pfizer, Moderna Vaccine Heart Warning

[ Price : $8.95]

FDAs Doran Fink says the agency will move quickly to add a Warning to Pfizer and Moderna Covid-19 vaccines about rare cases of myo...

Janssen NDA for Pediatric Use Xalrelto

[ Price : $8.95]

Janssen Pharmaceutical files an NDA for Xarelto (rivaroxaban), seeking its use in pediatric patients.

BLA Chemistry, Manufacturing and Control Changes Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approv...

Advisors Asked Whether to Delay Incyte Cancer Drug Deliberation

[ Price : $8.95]

FDA asks the Oncology Drugs Advisory Committee to assess whether there is sufficient clinical trial data on Incytes retifanlimab t...

EUA for B. Brauns Propofol-lipuro

[ Price : $8.95]

Federal Register notice: FDA announces for administrative purposes the issuance of an emergency use authorization to B. Braun Mels...

Reg Review Period for Alnylans Givlaari

[ Price : $8.95]

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

Merck Favorable Keytruda Data in Cervical Cancer

[ Price : $8.95]

Merck reports favorable data from a study investigating Keytruda (pembrolizumab) in combination with platinum-based chemotherapy f...

FDA TPLC Advisory Program Proposal

[ Price : $8.95]

FDA presents a proposal for a total product lifecycle advisory program to the 4/7 MDUFA 5 reauthorization negotiating session.

Standardized Study Data Electronic Format Guidance

[ Price : $8.95]

FDA issues a guidance with requirements for submitting standardized clinical and non-clinical drug study data in an approved elect...