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TXT Review Period Set for Victrelis [81 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Schering and Dendreon Corp.’s Victrelis for the purpose of patent extension.
06/27/2014
 
 
TXT Guidance on Nanotechnology and FDA-regulated Products [136 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.
06/27/2014
 
 
TXT FDA Approves Afrezza to Treat Diabetes [354 Words] [ Price : $8.95]
FDA approves a MannKind NDA for Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus.
06/27/2014
 
 
TXT FDA Completes EDAP Inspection for Ablatherm-HIFU PMA [96 Words] [ Price : $8.95]
FDA completes a routine inspection of an EDAP TMS manufacturing site that resulted in no Form-483 observations.
06/27/2014
 
 
TXT FDA Clears Encision’s Endoshield System [71 Words] [ Price : $8.95]
FDA clears an Encision 510(k) for its AEM Endoshield Burn Protection System for use in surgical procedures.
06/27/2014
 
 
TXT FDA Changes Records Subject to Privacy Act [136 Words] [ Price : $8.95]
Federal Register Notice: FDA deletes four system of records notices and adds routine uses for standard disclosures allowing disclosure that requires access to agency records subject to the Privacy Act.
06/27/2014
 
 
TXT 30 Months Later, FDA Denies Ex-Staffer's LASIK Petition [354 Words] [ Price : $8.95]
Thirty months after its submission, FDA denies a petition from former CDRH branch chief Morris Waxler seeking market withdrawal of LASIK eye surgery lasers and a safety-based public health advisory on them.
06/27/2014
 
 
TXT Shuren Takes on Critics of 23andMe and its Genomic Test [539 Words] [ Price : $8.95]
CDRH director Jeffrey Shuren takes on critics of the agency’s handling of genetic test maker 23andMe in a new agency blog posting.
06/27/2014
 
 
TXT New FujiFilm Mammography System Cleared [147 Words] [ Price : $8.95]
FDA clears a FujiFilm Medical Systems 510(k) for its Aspire Cristalle digital mammography system.
06/26/2014
 
 
TXT FDA Breakthrough Designation for Pradaxa Antidote Drug [138 Words] [ Price : $8.95]
FDA grants Boehringer Ingelheim Pharmaceuticals a breakthrough therapy designation for idarucizumab as an antidote for blood thinner Pradaxa.
06/26/2014
 
 
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