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TXT CBER Planning 14 Guidances This Year [2624 Words] [ Price : $8.95]
CBER releases a list of 14 guidances it expects to develop in this calendar year.
01/19/2017
 
 
TXT Roxane Secures First Generic Xyrem Approval [307 Words] [ Price : $8.95]
FDA says it has approved a Roxane Laboratories ANDA for the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution for treating cataplexy and excessive daytime sleepiness in patients with narcolepsy.
01/18/2017
 
 
TXT Trump’s FDA Commissioner Could Spur a Revolt [720 Words] [ Price : $8.95]
FDA Webview editor Jim Dickinson predicts internal FDA staff revolt if some of the named Trump commissioner nominees win the job and try to diminish current scientific standards, especially the efficacy requirement.
01/18/2017
 
 
TXT Ezra Innovations NDA for Hypertension Drug [1184 Words] [ Price : $8.95]
FDA accepts for review an Ezra Innovations NDA for investigational drug product EZR-104 for treating hypertension and heart failure.
01/18/2017
 
 
TXT Mallinckrodt Pays $100 Million in Antitrust Settlement [1248 Words] [ Price : $8.95]
Mallinckrodt agrees to pay $100 million to settle Federal Trade Commission charges that it violated antitrust laws when its subsidiary Questcor acquired the rights to a drug that threatened its monopoly in the U.S. market for adrenocorticotropic hormone drugs.
01/18/2017
 
 
TXT Draft Guide on Biosimilar Interchangeability [1144 Words] [ Price : $8.95]
Federal Register Notice: FDA makes available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.”
01/18/2017
 
 
TXT Guidance on Assessing Abuse Potential Drugs [1161 Words] [ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled “Assessment of Abuse Potential of Drugs.”
01/18/2017
 
 
TXT Symmetrel Not Withdrawn for Safety/Efficacy Reasons [1118 Words] [ Price : $8.95]
Federal Register Notice: FDA determines that Endo Pharmaceuticals’ Parkinson’s drug Symmetrel (amantadine hydrochloride), syrup, 50 milligrams/5 milliliters (50 mg/5 mL), was not withdrawn from sale for reasons of safety or effectiveness.
01/18/2017
 
 
TXT ‘Rethink’ Orphan Drug Incentives: Waxman [2853 Words] [ Price : $8.95]
Former Rep. Henry Waxman says some orphan drug financial incentives may no longer be needed because some companies are gaming the system to use them to charge exorbitant prices.
01/18/2017
 
 
TXT Califf Discusses Needed Changes With Advisory Committees [383 Words] [ Price : $8.95]
FDA commissioner Robert Califf says advisory committees are of questionable value in their current form and the agency is evaluating needed changes to the process.
01/18/2017
 
 
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