FDA Regulatory Consulting and Training Services

15
Jun

FDA Revokes Two Drugs CQ and HCQ Promoted by President Trump to Treat COVID-19

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

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12
Jun

FDA COVID-19 Related Guidances

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

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10
Jun

Pfizer COVID-19 Clinical Trials

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

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9
Jun

COVID-19 Developing Drugs and Biological Products

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

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6
Jun

Drugs or Vaccines Being Tested in Patients with 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

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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 Clinical Evaluation Working Group 5, Clinical Performance & Safety 2015-11-03 Last Updated: 2020-06-04

27
Jun

UK MHRA and BSI Statements In Response to Brexit Referendum

Dr. David Lim (Dr. Lim)’s Recommendations to the UK’s Health Authority, Medicines and Healthcare products Regulatory Agency (MHRA) and the BSI To the UK’s MHRA The MHRA should establish its own medical device approval/registration system within the principles of the EU’s medical device regulation or recognize other CE-marked devices available in the EU. Develop a process of recognizing other CE-marked devices Develop

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3
Jun

Global Adverse Event Databases

The United States Food and Drug Administration Mandatory Reporting According to Applicable Regulations Drugs and Biologics Drugs – FDA Adverse Event Reporting System (FAERS) Data Files Devices Medical Devices – MAUDE (Manufacturer and User Facility Device Experience) Vaccine Adverse Event Reporting System Australia – Therapeutic Goods Administration Database of Adverse Event Notifications (DAEN) The Therapeutic Goods Administration (TGA) receives adverse event reports associated with

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29
May

Glyphosate in Food and Vaccines May Be Linked to Autism

Glyphosate in Food Be Linked to Vaccines Leading to Autism? The potential connection between autism and vaccines has been disputed for a long time.  In the following video, Dr. Stephanie Seneff, Senior Research Scientist at MIT suggests a potential connection between glyphosate in food and vaccines contributing to autism. The United States Centers for Disease Control and Prevention (CDC e_stimates 1

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