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Drug and Device August 2023

Drug and Device August 2023

We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have.  If you wish for us to handle the annual requirements, please email Victoria Pankovich to get...
Drug and Device August 2023

Drug and Device July 2023

Thinking about an FDA gap assessment this year? Contact EAS now to schedule your 2023 audit. Schedules toward the end of the year tend to book up suddenly, now is the time to lock in your audit, whether it be onsite or virtual. We would be happy to prepare an audit...
Biofilms and Healthcare

Biofilms and Healthcare

Biofilms and Healthcare By David W Koenig, PhD., EAS Consulting Group Independent Consultant Healthcare facilities — such as hospitals, nursing homes and outpatient facilities — are opportunistic locations for acquiring secondary infections unrelated to a...
Drug and Device August 2023

Drug and Device June 2023

The FDA has published a new Guidance Document Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 which explains in great detail the GDUFA program user fee obligations. GDUFA III made slight changes to the user fee structure. (API facility fees...
Drug and Device August 2023

Drug and Device May 2023

As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December...