FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Comments Sought on Patient Experience Data

[ Price : $8.95]

Federal Register notice: FDA creates a public docket to collect comments on methodological challenges related to patient experienc...

OPDP Research on Drug Adherence Software

[ Price : $8.95]

Federal Register notice: CDERs Office of Prescription Drug Promotion proposed to conduct a study on Perceptions of Prescription D...

ID Certification Under FOIA

[ Price : $8.95]

Federal Register notice: FDA sends OMB an information collection extension entitled Certification of Identity for Freedom of Infor...

FDA Finishes Posting OTC Drug Deemed Final Orders

[ Price : $8.95]

With the 5/2 posting of five deemed final orders, FDA completes the process of posting 33 deemed final orders that was part of ove...

FDA Partial Hold on Sun JAK Inhibitor Trial

[ Price : $8.95]

FDA issues a partial clinical hold on Sun Pharmas Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia ...

Astellas/Pfizer Mulling sNDA for Xtandi

[ Price : $8.95]

Astellas Pharma and Pfizer plan to discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for...

BMS Files for Reblozyl Expanded Use

[ Price : $8.95]

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded in...

Bipartisan Bill on Preventing Drug Shortages

[ Price : $8.95]

Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) introduce bipartisan legislation to minimize and prevent future drug shor...

Complete Response on Hypoparathyroidism NDA

[ Price : $8.95]

FDA sends Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adu...

Princeton BioMeditech OTC Covid Test Authorized

[ Price : $8.95]

FDA issues Princeton BioMeditech an emergency use authorization for its Covid-19 Antigen Rapid Test for Home Use.