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TXT FDA Expects Operational Clozapine REMS by Year-end [2694 Words] [ Price : $8.95]
FDA says it believes that most clozapine REMS issues have been resolved and the program will be fully implemented by the end of 2016.
04/27/2016
 
 
TXT FDA ‘Complete Response’ on Digital Medicine Combo Product [182 Words] [ Price : $8.95]
FDA issues Otsuka Pharmaceutical Co. and Proteus Digital Health a complete response letter for their Digital Medicine, a drug/device combination product that combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in the tablet.
04/27/2016
 
 
TXT CGMP Deviations Found in Polydrug Labs Inspection [2894 Words] [ Price : $8.95]
FDA warns India’s Polydrug Laboratory about CGMP violations in its manufacturing of active pharmaceutical ingredients and blocks its U.S. shipments.
04/26/2016
 
 
TXT Latest FDA Warning Letters [555 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Benedict S. Liao, DMP Ltd., Infusion Options, Pharmaceutical Associates, and Polydrug Laboratories.
04/26/2016
 
 
TXT FDA Tells Catalyst it Needs More Firdapse Trials [2709 Words] [ Price : $8.95]
FDA tells Catalyst Pharmaceuticals it must conduct another trial of Firdapse in patients with Lambert-Eaton myasthenic syndrome and toxicology studies before its NDA can be accepted for filing.
04/26/2016
 
 
TXT QS Violations Cited at Greek Device Maker [2971 Words] [ Price : $8.95]
FDA warns Greece’s DMP Ltd. about multiple Quality System Regulation violations in its manufacturing of dental impression materials and composite resins.
04/26/2016
 
 
TXT FDA Clears Royal Philips CT Devices for Lung Cancer Screening [1146 Words] [ Price : $8.95]
FDA clears a Royal Philips 510(k) to market its computed tomography devices as a lung cancer screening center.
04/26/2016
 
 
TXT FDA Studying Diflucan Miscarriage Risk [2723 Words] [ Price : $8.95]
FDA calls for cautious prescribing of oral fluconazone in pregnancy while it evaluates results of a Danish study that found a possible increased risk of miscarriage with its use for yeast infections.
04/26/2016
 
 
TXT FDA Releases New, Updated Medication Guides [2621 Words] [ Price : $8.95]
FDA releases three new and 10 updated Medication Guides.
04/26/2016
 
 
TXT Stakeholders Want Compounding Law Fully Funded [2777 Words] [ Price : $8.95]
Six stakeholder groups will urge the Senate Appropriations Committee to fully fund FDA oversight of compounding pharmacies.
04/26/2016
 
 
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