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TXT Cleveland Clinic 3D Airway Stents Cleared [186 Words] [ Price : $8.95]
FDA clears a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea.
01/15/2020
 
 
TXT Oncology Pediatric Study Plans Guide [77 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Study Plans for Oncology Drugs: Questions and Answers.”
01/15/2020
 
 
TXT Device PMA Advisory Meetings Disappearing: Attorneys [2689 Words] [ Price : $8.95]
Attorneys Jeffrey Gibbs and McKenzie Cato say that FDA advisory committee meetings to review product applications may become a thing of the past.
01/15/2020
 
 
TXT Clovis sNDA for Rubraca Accepted for Review [138 Words] [ Price : $8.95]
FDA accepts for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in certain dult patients with prostate cancer.
01/15/2020
 
 
TXT Neovasc PMA for Reducer Accepted for Review [142 Words] [ Price : $8.95]
FDA accepts for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina.
01/15/2020
 
 
TXT Joint Panel Nixes Nektar’s Back Pain Drug [108 Words] [ Price : $8.95]
An FDA joint advisory committee votes 27 to 0 to not recommend approval of Nektar Therapeutics’ oxycodegol for back pain.
01/15/2020
 
 
TXT FDA Updates List of Deemed BLAs [2631 Words] [ Price : $8.95]
FDA updates the list of biological products that will be deemed to be BLAs on 3/23 to include chemically synthesized polypeptides.
01/15/2020
 
 
TXT McDermott Will & Emery FDA 2019 Review [2948 Words] [ Price : $8.95]
A McDermott Will & Emery review of FDA activities in 2019 finds a slight decrease in overall enforcement activity as the agency continues focusing on a risk-based approach.
01/15/2020
 
 
TXT Lannett Cocaine Nasal Anesthetic Approved [87 Words] [ Price : $8.95]
FDA approves a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), indicated for the introduction of local anesthesia in the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
01/15/2020
 
 
TXT FDA Still Questions Durect’s Posimir [2781 Words] [ Price : $8.95]
FDA asks members of the Anesthetic and Analgesia Drug Products Advisory Committee to evaluate whether Durect has provided sufficient efficacy and safety information to support approval of its NDA for Posimir.
01/15/2020
 
 
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