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Drug and Device July 2024

Drug and Device July 2024

FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory....
Import Refusals – “Don’t Panic”

Import Refusals – “Don’t Panic”

Import Refusals – “Don’t Panic” By Mark Moen, EAS Consulting Group Senior Regulatory Consultant Products imported into the US may be assessed and inspected by US Customs and Border Protection (CBP), the Food and Drug Administration (FDA), and US Consumer Products...