FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments on OPDP Research Proposal

[ Price : $8.95]

Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.

2 Drugs Have Positive Effect on Alzheimers Disease: Study

[ Price : $8.95]

University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and im...

Breakthrough Designation for Janssens Talquetamab

[ Price : $8.95]

FDA grants breakthrough therapy designation to Janssens talquetamab for some multiple myeloma patients.

Fit-For-Purpose Clinical Outcome Assessment Guidance

[ Price : $8.95]

FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health th...

FDA Determines Regulatory Review Period for Rukobia

[ Price : $8.95]

Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia ...

Regulatory Review Period for Danyelza

[ Price : $8.95]

Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics ...

FDA Will Review Eylea sBLA for an Extended Dosing Regimen

[ Price : $8.95]

FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with dia...

Attorneys See Renewed DoJ Interest in Fraud-on-FDA

[ Price : $8.95]

A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.

Improve FDA Foreign For-Cause Inspections: OIG

[ Price : $8.95]

The HHS Inspector General says FDA agrees with its recommendations to improve foreign for-cause drug inspections.

Invictus Sterilization Air Purifier Cleared

[ Price : $8.95]

FDA clears an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier that is intended to inactivate bac...