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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...

Labeling and IFU Compliance Soon to Follow EU MDR Transition

February 22, 2021
OTC

Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helped them in organizing the labeling and instructions for use associated with their medical devices....

EU MDR Transition, General Labeling Requirements under EU, Medical Device Labeling, Medical Device Labeling Regulations, medical device labeling requirements, medical device labels

Regulatory Intelligence is a key to Quality and Safety

January 29, 2021
Standards

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on...

Regulatory Affairs, Regulatory Changes, Regulatory Database, Regulatory Intelligence, Regulatory Intelligence for Biopharma, Regulatory Intelligence for Cosmetics, Regulatory Intelligence for Food Supplements, Regulatory Intelligence for Medical Devices