Blogs
FDA Warning Letter Jan-Apr 2021 Recap…
Warning DescriptionProducts & SummaryFDA has seen manufacturer’s Website and their claims on prod…
Labeling Requirements for Prescriptio…
Under FDA there are more than 150 labeling resources that are present for labeling prescription drugs…
Medical Device Labeling under FDA
Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on foo…
EU Regulations: Things Still to be known
Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical …
Labeling and IFU Compliance Soon to F…
Multiple manufacturers are seeing postponement of the EU MDR as a boon. This one-year delay has helpe…
Regulatory Intelligence is a key to Q…
Organizations often face unforeseen risks when they tread on the uncommon roads of the life science s…
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