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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.
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.
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.
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.
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.
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.
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.
TXT Proposal Withdrawn on Cranial Electrotherapy Stimulator [64 Words] [ Price : $8.95]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.
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.
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.
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