Drug and Device Corner October 2022
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below....Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
The Role of Your US Agent
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
Drug and Device Corner September 2022
As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops. EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent...