FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Industry Using Political Clout to Block Biosimilars: Public Citizen

[ Price : $8.95]

Public Citizen says the biologics industry has used its political power to delay marketing of generic biologics.

FDA Sends Collection of Info on Fast-Track Drugs to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a guidance on fast track drug development programs to...

Info on Orphan Products Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a draft guidan...

Guidance on Study Data E-Submissions

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Info on Biologic Cooperative Manufacturing Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Guidance on E-Format Submissions Under FDCA 745A(a)

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Submissions Under Section...

FDA Proposes Electronic Prescribing Info on Drugs/Biologics

[ Price : $8.95]

Federal Register Proposed rule: FDA proposed to amends is prescription drug and biological product labeling regulations to require...

FDA Mulls Changes to Drug-induced Liver Injury Guidance

[ Price : $8.95]

FDA seeks input on potential revisions to a 2009 guidance on Drug-Induced Liver Injury: Premarketing Clinical Evaluation, which is...

FDA Testing Drone Technology, But Not for Inspections

[ Price : $8.95]

FDA says it is testing drone technology as part of its Office of Informatics and Technology Innovation emerging technologies resea...

FDA Approves Cerus Plasma Pathogen Reduction Device

[ Price : $8.95]

FDA approves a Cerus Corp. BLA for its Intercept Blood System for plasma, a pathogen reduction system for reducing the risk of tra...