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TXT FDA Priority Review for AbbVie Hep C NDA [83 Words] [ Price : $8.95]
FDA accepts for priority review an AbbVie NDA for its investigational, all-oral, interferon-free regimen for treating of adult patients with chronic genotype 1 hepatitis C virus infection.
06/13/2014
 
 
TXT Axid Discontinued, No Pediatric Study: Braintree [237 Words] [ Price : $8.95]
Braintree says it will not pursue a study of Axid in pediatric patients under the Pediatric Research Equity Act because it has discontinued commercial distribution of the drug.
06/12/2014
 
 
TXT OPDP Says Suprenza Web Site is ‘False and Misleading’ [482 Words] [ Price : $8.95]
CDER’s Office of Prescription Drug Promotion sends an untitled letter to Citius Pharmaceuticals detailing items it says are false and misleading in a Suprenza Web page.
06/12/2014
 
 
TXT Study Sheds Light on Protein Info Highway for Drug Discovery [297 Words] [ Price : $8.95]
A study by the scientists at the Institute for Research in Biomedicine at Barcelona reveals the existence of information highways that connect and correlate distant sites within a single protein, which can be beneficial for drug discovery.
06/12/2014
 
 
TXT Info on Drug Producer Registration Sent to OMB [53 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on registration of producers of drugs and listing of drugs in commercial distribution to the Office of Management and Budget.
06/12/2014
 
 
TXT Review Period Set for Arcapta Neohaler [66 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Novartis’ Arcapta Neohaler for the purpose of patent extension.
06/12/2014
 
 
TXT Review Period Set for Arctic Front Cryocatheter System [51 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Medtronic CyroCath’s Arctic Front Cryocatheter System for the purpose of patent extension.
06/12/2014
 
 
TXT Proposal Withdrawn on Cranial Electrotherapy Stimulator [64 Words] [ Price : $8.95]
Federal Register Withdrawal of proposed rule: FDA withdraws a proposed rule that would require the filing of a PMA or a notice of completion of a product development protocol for cranial electrotherapy stimulator.
06/12/2014
 
 
TXT NC Considering Restricting Suits Against Drug Companies [368 Words] [ Price : $8.95]
The North Carolina Senate approves and sends to the House legislation including a provision that would grant drug companies a presumption in court that they are without fault if they have warned about specific side effects and have followed all FDA rules.
06/12/2014
 
 
TXT Medtronic Final PMA Module for INPACT Balloon [150 Words] [ Price : $8.95]
Medtronic files its final module on a PMA for the INPACT Admiral drug-coated balloon for use in angioplasty procedures.
06/12/2014
 
 
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