The US FDA Has Revoked the Emergency Use Authorizations (EUA) of Chloroquine and Hydroxychloroquine to Treat COVID-19 The US FDA Has Revoked the Emergency Use Authorizations (EUA) for emergency use of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to treat the COVID-19 disease because BARDA concluded, based on clinical trial data results, that the drug’s potential benefits do not outweigh
COVID-19-Related FDA Guidances The following list of FDA guidances provide recommendations to industry regarding biologics, biologics/drugs, biologics/medical devices, drugs, drugs/biologics, biologics/medical devices, medical devices, food & beverages, biologics, drugs and medical devices during a COVID-19 pandemic. These guidances discuss FDA’s intended approach to enforcement of regulatory (compliance) requirements for medical products and dietary supplements during a pandemic. Biologics (with Drugs
Pfizer: Clinical Trials on COVID-19 Pfizer, a multinational biopharmaceucal giant, is testing few drugs on COVID-19. Xeljanz (tofacitinib) In a multicenter, randomized, double-blind, placebo-controlled, parallel study (phase 2), it is currently evaluating the safety and efficacy of tofacitinib in hospitalized adult subjects* (N=240) with COVID-19 pneumonia. *: subjects with lab confirmed SARS-CoV infection as determined by a positive PCR or
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention During the Coronavirus Disease 2019 (COVID-19) pandemic, US Food and Drug Administration (FDA) has issued a guidance to assist sponsors in clinically developing drugs and biological products intended to treat or prevent COVID-19. This guidance doesn’t address preventative vaccines and plasma (convalescent). This guidance is in effect during the COVID-19
Drugs or Vaccines in Phase 2 Clinical Trials in Patients with COVID-19 This is as of June 7, 2020. For the interest of understanding currently ongoing clinical trials for a list of representative drugs in patients with COVID-19, the following provides a list of drugs which are currently being tested in phase II clinical trials. In other words, this is
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
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
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
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
