Regulatory Doctor

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. [youtube_advanced url=”https://www.youtube.com/watch?v=P3Psn_p9_0s” controls=”no” loop=”yes” rel=”no” modestbranding=”yes”] The United States Centers for Disease

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20
May

Movie for Chasing the Dragon – Opioid Addiction

Opioid Addiction Chasing the Dragon: The Life of an Opiate Addict The following movie is for awareness purposes regarding Opioid Addiction in the US.  In the US, it has been a growing epidemic of prescription drug and heroin abuse. The US FBI and DEA have released a movie entitled “Chasing the Dragon: The Life of an Opiate Addict“, a documentary

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26
Apr

21 CFR 820.70 Production and Process Controls

21 CFR PART 820 QUALITY SYSTEM REGULATION Subpart G–Production and Process Controls 820.70 Production and process controls (a) General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control

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22
Apr

FDA Proposes Ban on Electrical Stimulation Devices

Electrical Stimulation Devices (ESDs) ESDs Are Intended to Treat Self-injurious or Aggressive Behavior The United States Food and Drug Administration (FDA) is proposing ban on ESDs because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. Aversive conditioning devices were on the market prior to passage of the Medical

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19
Apr

FDA Reclassifies Cardiovascular EPPG and PSA Devices into Class II

FDA Final Order for Medical Device Reclassification Reclassification of Cardiovascular Devices External Pacemaker Pulse Generator and Pacing System Analyzers 21 CFR Part 870 FDA issues Final Order, effective as of April 18, 2016, to reclassify external pacemaker pulse generator (EPPG) as well as to create a separate classification regulation for pacing system analyzers (PSAs) devices and reclassify PSA devices into

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6
Apr

FDA Approved an IND for Zika Virus

U.S. Food and Drug Administration An IND Approved for Zika Virus The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus.  The test is manufactured by Roche Molecular Systems, Inc. (Roche). *: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of

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24
Mar

Don't Hesitate to Say I Am Sorry After Medical Errors

A woman patient, Deborah Craven (60) is now suing prominent surgeons and the Yale University Hospital in New Haven, CT after receiving a wrong operation, removing the wrong body part (rib).  The patient ended up getting two surgeries in one day. Her lawyer states she is suing because she never heard the two words “I am sorry.” Read more from CNN

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23
Mar

US Congressman Sent a Letter to Veterans Affairs Not to Allow Essure

Hon. Mike Fitzpatrick Sent a Letter to the Veterans Affairs and Related Agencies Not to Purchase Medical Device Essure March 1, 2016 The Honorable Charlie Dent Chairman Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC-227 The Capitol Washington, DC 20515 The Honorable Sanford Bishop, Jr. Ranking Member Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC- 227

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