FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

40 Safety Signal Listings

[ Price : $8.95]

FDA releases the October-December 2021 safety signal report with 40 listings from the FDA Adverse Events Reporting System.

Medtronic Renal System Lowered Blood Pressure: Trial

[ Price : $8.95]

Medtronic says a clinical trial showed that patients who were prescribed anti-hypertensive medications and treated with its Sympli...

FDA OKs Igalmi for Schizophrenia/Bipolar Agitation

[ Price : $8.95]

FDA approves a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associat...

FDA to Decide in June on Next Booster Compostion

[ Price : $8.95]

FDA officials say that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November ...

Comments on Presser Assessment Guidance

[ Price : $8.95]

Six drug companies comment on an FDA draft guidance on assessing drug presser effects.

FDA Lists 6 OMB-approved Info Collections

[ Price : $8.95]

Federal Register notice: FDA announces that six information collections that have been approved by OMB.

FDA to Rate Drug Firms Quality Management Maturity

[ Price : $8.95]

A new FDA whitepaper outlines the agencys plans to advance a framework to objectively rate pharmaceutical manufacturing sites Qual...

Priority Review for Dupixent sBLA

[ Price : $8.95]

FDA grants priority review for Sanofi and Regenerons sBLA for a new Dupixent indication.

Novartis Gene Therapy Facility Approved by FDA

[ Price : $8.95]

FDA gives commercial licensure approval to a second Novartis gene therapy manufacturing facility, this one in Durham, NC.

FDA Participating in EHR Integration Project

[ Price : $8.95]

FDA participates in the OneSource electronic health record data integration project.