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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.

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FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and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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FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products

FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products

The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical...

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Cosmetic Safety Substantiation

Cosmetic Safety Substantiation

Presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory ConsultantJuly 25, 2024 • 11:00am - 1:00pm (Eastern)The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) became effective in December 2023 and includes a requirement for safety substantiation. MoCRA is an amendment to the...

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Drug and Device December 2023

Drug and Device December 2023

With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program –...

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21 CFR Part 11 and FDA Compliance

21 CFR Part 11 and FDA Compliance

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA ComplianceAn EAS Complimentary Webinar Presented by Carolyn Troiano, EAS Independent ConsultantNovember 8, 2023 • 1:00 pm – 4:00 pm (ET); 3 HoursEnter Your Information to Watch NowBy clicking submit above, you consent to allow EAS Consulting Group...

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