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EAS Blog

EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.

Drug and Device May 2024

Drug and Device May 2024

Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic address, domestic phone number,...

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Drug and Device April 2024

Drug and Device April 2024

FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024.  The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics,...

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Drug and Device March 2024

Drug and Device March 2024

Reminder that CARES volume 2023 reports are due no later than 1 July 2024.Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug establishments in submitting...

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Reassessment of EMPs

Reassessment of EMPs

Reassessment of EMPs: Have You Identified the Correct Sampling Locations to Protect Your Product?An EAS Complimentary Webinar Presented by Rocelle Grabarek, EAS Independent ConsultantMarch 27, 2024 • 1pm (Eastern) 1.5 hoursMany of the environmental monitoring programs (EMP) have been established...

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Conducting Remote Regulatory Assessments Questions and Answers

Conducting Remote Regulatory Assessments Questions and Answers

FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, meet...

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