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Adverse Reaction Reporting Guide for New Zealand

June 2, 2021
Standards

New Zealand tends to have a high rate when it comes to adverse reaction reporting. The Centre for Adverse Reactions Monitoring (CARM), Dunedin acts as the national repository. This entire data helps...

adverse drug reactions, centre for Adverse Reactions monitoring, guide for adverse reaction reports, pharmacists.

Unique Device Identification System

May 13, 2021
Medical Device

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented,...

FDA requires medical device labelers, GUDID, Medical Devices, Medical Devices Labeling, UDI, Unique Device Identification System

FDA Warning Letter Jan-Apr 2021 Recap Summary

May 6, 2021
Standards

Warning DescriptionProducts & SummaryFDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance...

The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19.

Labeling Requirements for Prescription Drugs

March 24, 2021
Digital Health

Under FDA there are more than 150 labeling resources that are present for labeling prescription drugs. FDA has approved about 50+ guidances to be used while labelling cartons and containers containing...

Medical Device Labeling under FDA

March 23, 2021
Medical Device

Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on food, drugs, medical devices, biologics, cosmetics and even radiation emitting electronic products....

FDA Labeling Requirements, Labeling requirements for Medical Devices, Medical Device Labeling, medical device labeling requirements, medical device labels, Medical device regulatory requirements

EU Regulations: Things Still to be known

February 22, 2021
Medical Device

Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical science changes. Manufacturers will regard the new regulations as a benchmark globally as it would...