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TXT CDER Task Force to Help Develop New Antibiotics [207 Words] [ Price : $8.95]
FDA creates a task force to help stimulate new antibiotic development.
07/28/2014
 
 
TXT Docket Established on Proprietary Drug Names [83 Words] [ Price : $8.95]
Federal Register Notice: FDA establishes a public docket to discuss reserving proprietary names for drug products.
07/28/2014
 
 
TXT Panel to Discuss Forest NDA for Hypertension [92 Words] [ Price : $8.95]
Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 9/9 to discuss a Forest Labs NDA for nebivolol/valsartan combination tablets for treating hypertension.
07/28/2014
 
 
TXT FDA Rejects Petition on Halting Changes to 510(k) Program [325 Words] [ Price : $8.95]
FDA denies a citizen petition filed by the Minnesota Medical Device Alliance (MMDA) that challenged FDAs current practices in reviewing 510(k)s.
07/28/2014
 
 
TXT Public Citizen Seeks Warning on OTC Benzocaine [229 Words] [ Price : $8.95]
Public Citizen petitions FDA urging that it not allow over-the-counter benzocaine products to be marketed for treating teething in infants and toddlers because they can cause a rare but potentially deadly adverse reaction.
07/28/2014
 
 
TXT House Panel Wants Answers to FDA, NIH Smallpox Gaffe [115 Words] [ Price : $8.95]
A House Committee writes FDA commissioner Margaret Hamburg for answers to questions on how FDA and NIH handle dangerous archived biological samples that are housed in agency-controlled laboratories in the wake of the recent smallpox fiasco.
07/28/2014
 
 
TXT FDA Rejects AcelRx NDA for Pain Combo Product [172 Words] [ Price : $8.95]
FDA sends AcelRx Pharmaceuticals a complete response letter on its NDA for Zalviso (sufentanil sublingual tablet system), a drug-device combination product seeking an indication for treating pain.
07/28/2014
 
 
TXT FDA Approves Expanded Use for Imbruvica [177 Words] [ Price : $8.95]
FDA approves an expanded use for Pharmacyclics and Janssen Biotechs Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion).
07/28/2014
 
 
TXT OMB OKs Animal Generic Drug User Fees [44 Words] [ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on the animal generic drug user fee cover sheet.
07/28/2014
 
 
TXT Guidance on the 510(k) Program [75 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
07/28/2014
 
 
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