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TXT FDA Clears Monteris Medical NeuroBlate System [146 Words] [ Price : $7.95]
FDA clears a Monteris Medical 510(k) for the NeuroBlate System, an MRI-guided ablation device for brain tumors and other lesions.
04/08/2013
 
 
TXT Duke Researchers Find Concerns with Ongoing Diabetes Trials [362 Words] [ Price : $7.95]
Duke University researchers say an analysis of worldwide diabetes trials finds that they are not addressing key issues relating to the condition.
04/08/2013
 
 
TXT FDA Releases Product-Specific BE Guidance [36 Words] [ Price : $7.95]
Federal Register Notice: FDA releases additional product-specific bioequivalence recommendations.
04/08/2013
 
 
TXT FDA Implementing Administrative Detentions for Drugs Provision [204 Words] [ Price : $7.95]
FDA begins implementing an FDA Safety and Innovation Act provision giving it authority to administratively detain drug products.
04/08/2013
 
 
TXT Lawyers See New Generic Drug Liability in Labeling Case [388 Words] [ Price : $7.95]
Food and drug lawyers see heightened liability for generic drug makers in a recent drug preemption case involving warning labels.
04/08/2013
 
 
TXT Info on Restricting Tobacco Sales Sent to OMB [59 Words] [ Price : $7.95]
Federal Register Notice: FDA submits a proposed collection of information on regulations restricting cigarette and smokeless tobacco sales to children to the Office of Management and Budget.
04/08/2013
 
 
TXT CBER Invites Participants for eSubmitter Pilot [75 Words] [ Price : $7.95]
Federal Register Notice: CBER is inviting sponsors of IND applications to participate in the eSubmitter pilot program to facilitate creation of IND applications in electronic format.
04/08/2013
 
 
TXT Since Our Last Issue ... [493 Words] [ Price : $7.95]
Industry news you may have missed since our last issue.
04/07/2013
 
 
TXT Product Approval Summaries [547 Words] [ Price : $7.95]
FDA Review posts product approval summaries for the week ending 4/5/2013.
04/07/2013
 
 
TXT Federal Judge Orders FDA to Lift Restrictions on OTC Plan B [895 Words] [ Price : $7.95]
A New York federal judge orders FDA to approve within 30 days a previously denied citizen petition to allow levonorgestrel-based emergency (Plan B) contraceptives available without a prescription and without point-of-sale or age restrictions.
04/05/2013
 
 
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