Staff Editor

6
Jun

Specialty Infusion Therapy Drugs

Specialty Infusion Therapy and Drugs Specialty infusion therapy drugs are prescribed for the treatment of both chronic and acute illnesses at home or in the outpatient setting.   About 33% of total drug costs are incurred by specialty drugs according to the 2015 Express Scripts’ Drug Trend Report (PDF available here >>). In 2018, specialty drugs comprised of 44.2% to overall

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19
Oct

AHWP WG5 Clinical Evaluation

AHWP WG5 Clinical Evaluation Asian Asian Harmonization Working Party (AHWP) AHWP is established as a non-profit organization. Its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions and to work in coordination with the Global Harmonization Task Force, APEC and other related international organizations aiming at establishing harmonized requirements, procedures and

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24
Nov

Ablation Catheter Approved to Treat Arrhythmia

FDA PMA Approval TactiCath Quartz Contact Force Ablation Catheter and TactiSys Quartz Equipment – P130026 FDA Approval Letter for P130026, Dated October 24, 2014 Summary of Safety and Effectiveness Data (SSED) and Labeling What is it? The TactiCath Quartz Contact Force Ablation Catheter (TactiCath) is a flexible catheter used to treat a certain kind of abnormal heart rhythm (arrhythmia) called paroxysmal

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20
Nov

Common Moles Dysplastic Nevi and Risk of Melanoma

Moles, Dysplastic Nevi, and Risk of Melanoma Key Points A common mole (nevus) is a small growth on the skin that is usually pink, tan, or brown and has a distinct edge. People who have more than 50 common moles have a greater chance than others of developing a dangerous type of skin cancer known as melanoma. Most common moles

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19
Nov

Report for Medication Therapy Management Interventions in Outpatient Settings

By Regulatory Doctor LinkedIn Google Plus Twitter Facebook Comparative Effectiveness Review Medication Therapy Management Interventions in Outpatient Settings This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products

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