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TXT Reject Teva Petition on Rescue Inhaler Counters: Mylan [264 Words] [ Price : $8.95]
Mylan urges FDA to deny a Teva petition that would impose testing requirements on sponsors of ANDAs for rescue inhalers with integrated dose counters.
08/21/2014
 
 
TXT Concerns About FDA Regulating Through Guidance [540 Words] [ Price : $8.95]
Attorney Gail Javitt says FDA’s plan to regulate clinical laboratories and laboratory-developed tests through two guidances violates administrative procedure requirements.
08/21/2014
 
 
TXT FDA Enhancing Trial Data Collection, Availability [453 Words] [ Price : $8.95]
FDA commissioner Margaret Hamburg says the agency is issuing an action plan and guidance to improve collection and reporting of clinical trial data by various demographic subgroups.
08/20/2014
 
 
TXT FDA Proposing ‘Master Protocol’ for Breast Cancer Trials [437 Words] [ Price : $8.95]
FDA coordinates a public workshop to advance a proposed “master protocol” for conducting trials in patients with metastatic breast cancer.
08/20/2014
 
 
TXT FDA Sends Info on Temporary Marketing Permits to OMB [51 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on temporary marketing permit applications to the Office of Management and Budget.
08/20/2014
 
 
TXT Lupron Depot-Ped Not Withdrawn for S&E [159 Words] [ Price : $8.95]
Federal Register Notice: FDA determines that Lupron Depot-Ped Injectable 3.75 mg/vial and 7.5 mg/vial; and 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness.
08/20/2014
 
 
TXT CDRH Posts UDI Frequently-asked Questions Guidance [101 Words] [ Price : $8.95]
CDRH posts a guidance on Unique Device Identification (UDI) System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff.
08/20/2014
 
 
TXT FDA Loses Against Hospira in Precedex Carve-out Decision [216 Words] [ Price : $8.95]
The Maryland federal district court grants Hospira a temporary restraining order against FDA after the company challenged an agency 8/18 determination on potential ANDAs for the company’s sedation drug Precedex.
08/20/2014
 
 
TXT Marck Biosciences Changes Its Name [253 Words] [ Price : $8.95]
A European Compliance Academy online newsletter discloses that India’s Marck Biosciences changed its name shortly before a very critical FDA Warning Letter was issued.
08/20/2014
 
 
TXT FDA Speeding PMA Approvals: Analysis [377 Words] [ Price : $8.95]
EPVantage’s Medtech review of the first half of 2014 says that FDA is speeding PMA approvals and planning an expedited review for innovative medical devices.
08/20/2014
 
 
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