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Ivacaftor
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51	Contains Nonbinding Recommendations Draft Guidance on Ivacaftor This draft guidance, once finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or co Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Bioequivalence Pharmacokinetics Dissolution testing Abbreviated New Drug Application Generic drug Ivacaftor Food and Drug Administration Pharmaceutical sciences Pharmaceutical industry Pharmacology
52	Stakeholder meeting statement Pharmaceutical Benefits Scheme listing of ivacaftor (Kalydeco) for cystic fibrosis A stakeholder meeting was held on 31 July 2014 to discuss the Pharmaceutical Benefits Scheme (PBS) listing Add to Reading List Source URL: www.pbs.gov.au Language: English - Date: 2014-10-01 21:51:53 Channelopathy Cystic fibrosis Pediatrics Ivacaftor Spirometry Pharmaceutical Benefits Scheme Clinical trial Health Medicine Pulmonology
53	Stakeholder meeting statement Pharmaceutical Benefits Scheme listing of ivacaftor (Kalydeco) for cystic fibrosis A stakeholder meeting was held on 31 July 2014 to discuss the Pharmaceutical Benefits Scheme (PBS) listing Add to Reading List Source URL: www.pbs.gov.au Language: English - Date: 2014-10-01 21:51:53 Channelopathy Cystic fibrosis Pediatrics Ivacaftor Spirometry Pharmaceutical Benefits Scheme Clinical trial Health Medicine Pulmonology
54	Microsoft Word[removed]CFTR research protocol_final ratified Nov 2014-accessible.docx Add to Reading List Source URL: www.msac.gov.au Language: English - Date: 2014-11-19 23:54:21 Clinical research Design of experiments Epidemiology Pancreas disorders Pediatrics Cystic fibrosis Congenital absence of the vas deferens Ivacaftor Sweat test Health Medicine Biology
55	28 April[removed]Update on the PBAC review of KALYDECO™ (ivacaftor) in Australia Add to Reading List Source URL: www.vrtx.com Language: English - Date: 2014-04-27 11:04:26 Pharmaceutical Benefits Scheme Pharmaceuticals policy Ivacaftor Cystic fibrosis Health Medicine Healthcare in Australia
56	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. -------------------------------CONT Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2015-01-09 16:45:07 Phenols Anilides Ivacaftor Quinolones Cystic fibrosis Vertex Pharmaceuticals Placebo Health Medicine Biology
57	Microsoft Word - Kalydeco Add to Reading List Source URL: www.medicaid.ms.gov Language: English - Date: 2014-12-30 15:06:26 Triazoles Alcohols Organofluorides Piperazines Voriconazole Azole Ivacaftor Telithromycin Ketoconazole Chemistry Organic chemistry Antifungals
58	Temporary Compliance Waiver Notice At the time of initial posting on October 28, 2014 the attached PDF document may not be fully accessible to readers using assistive technology. A fully accessible version of the documen Add to Reading List Source URL: www.fda.gov Language: English Anilides Ivacaftor Phenols Quinolones Pancreas disorders Cystic fibrosis Chloride channel Cystic Fibrosis Foundation Ion channel Biology Health Protein families
59	Beneficiary Full Name: ___________________________________________ Sponsor’s SSN: ______-_____-_______ Date of Birth: ____________________________________ Beneficiary State of Residence: _______________ Dear Provide Add to Reading List Source URL: www.hnfs.com Language: English - Date: 2015-01-03 22:28:31 Pediatrics Channelopathy Cystic fibrosis Ivacaftor Genetic testing TRICARE Male infertility Health Medicine Biology
60	FOOD AND DRUG ADMINISTRATION Add to Reading List Source URL: www.fda.gov Language: English Ivacaftor Phenols Quinolones Cystic fibrosis Medicine Biology Vertex Pharmaceuticals VX-809 Health Pancreas disorders Anilides

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