FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide Revised on Covid-19 Diagnostic Tests

[ Price : $8.95]

FDA revises a 3/26 guidance entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Pfizer/BioNTech Covid Vaccine Begins Study

[ Price : $8.95]

Pfizer and BioNTech say that the first participants have been dosed in the U.S. in a Phase 1/2 clinical trial for their BNT162 vac...

MDR Violations Found at Philosys Company

[ Price : $8.95]

FDA warns Koreas Philosys Co. Ltd. about medical device reporting violations in its manufacturing of blood glucose test systems.

Shriram Institute FDA Inspection Found CGMP Issues

[ Price : $8.95]

FDA warns Indias Shriram Institute for Industrial Research about CGMP violations and deviations in its work as a contract testing ...

Comments on Including Older Adults in Cancer Trials

[ Price : $8.95]

Three stakeholders express support for an FDA guidance on including older adults in cancer clinical trials.

No Lonsurf Carve-Out: Taiho Petition

[ Price : $8.95]

Taiho Oncology says FDA should not permit ANDA applicants for generic forms of its Lonsurf to carve out part of the labeling relat...

BrioMD Unapproved Cellular Treatment

[ Price : $8.95]

CBER says BioMD is marketing an unapproved human cell, tissue, or cellular or tissue-based product.

Seize Mifepristone Web Site Domains: Groups

[ Price : $8.95]

Some 56 advocacy groups representing pro-life and other interests urge FDA to seize Web site domains selling mifepristone and othe...

Lipocine Proposes Phase 2 Trial for Cirrhosis Drug

[ Price : $8.95]

FDA accepts a Lipocine IND to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an ora...

Guide on Posterior Cervical Screw Classification

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Classification of Posterior Cervical Screw Systems: Small E...