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TXT Industry Using ‘Political Clout’ to Block Biosimilars: Public Citizen [394 Words] [ Price : $8.95]
Public Citizen says the biologics industry has used its political power to delay marketing of generic biologics.
12/18/2014
 
 
TXT FDA Sends Collection of Info on Fast-Track Drugs to OMB [52 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on fast track drug development programs to the Office of Management and Budget.
12/18/2014
 
 
TXT Info on Orphan Products Sent to OMB [59 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a draft guidance on meetings with the Office of Orphan Products Development.
12/18/2014
 
 
TXT Guidance on Study Data E-Submissions [77 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format — Standardized Study Data.
12/18/2014
 
 
TXT Info on Biologic Cooperative Manufacturing Sent to OMB [48 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on cooperative manufacturing arrangements for licensed biologics.
12/18/2014
 
 
TXT Guidance on E-Format Submissions Under FDCA 745A(a) [72 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.
12/18/2014
 
 
TXT FDA Proposes Electronic Prescribing Info on Drugs/Biologics [113 Words] [ Price : $8.95]
Federal Register Proposed rule: FDA proposed to amends is prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information.
12/18/2014
 
 
TXT FDA Approves Cerus Plasma Pathogen Reduction Device [155 Words] [ 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 transfusion-transmitted infections.
12/17/2014
 
 
TXT Appeals Court Affirms Bayer Whistleblower Award [164 Words] [ Price : $8.95]
A federal appeals court affirms most of an Arkansas federal jury award to a Bayer Corp. sales representative who was allegedly fired in retaliation for reporting a physician’s Medicaid scam.
12/17/2014
 
 
TXT Electronic Format Guidances Out [2907 Words] [ Price : $8.95]
FDA issues its first two guidances implementing new legal provisions relating to regulatory submissions in electronic format.
12/17/2014
 
 
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