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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.

Certified Group Welcomes Amanda Bosse as CEO

Certified Group Welcomes Amanda Bosse as CEO

CEO transition to strengthen and accelerate the company’s growth by driving innovation in the lab testing market and expanding production capacity to better serve customersSAN ANTONIO, Aug. 25, 2022 /PRNewswire/ – Certified Group, a leading provider of testing and regulatory consulting services in...

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Adverse Event Reporting for OTC Drug Products

Adverse Event Reporting for OTC Drug Products

By Susan Crane, EAS Senior Advisor for OTC Drugs and LabelingAs part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations established by the agency that...

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Responding to an FDA Notice of Action

Responding to an FDA Notice of Action

Timing is EverythingWhen importing FDA-regulated products into the U.S., time is money. So, when you receive an FDA Notice of Action, a prompt and appropriate response will expedite what comes next. Nearly 15% of U.S. imports are FDA-regulated products. That amounts to nearly $2.5 billion of goods...

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FDA Expands Use of Remote Regulatory Assessments (RRA)

FDA Expands Use of Remote Regulatory Assessments (RRA)

What You Need to KnowFDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part of a risk-based approach when...

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Food Allergens and the FDA

Food Allergens and the FDA

An EAS and Food Safety News Complimentary Webinar. What’s Happening. Presented by Steve Gendel, EAS Independent Consultant. As we approach 20 years since the passage of the Food Allergen Control and Consumer Protection Act of 2004 (FALCPA), industry and the FDA continue to struggle with many...

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Environmental Monitoring Programs in Tablets and Capsules Magazine

Environmental Monitoring Programs in Tablets and Capsules Magazine

EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers assistance with design and...

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What is Chemical Testing in Food?

What is Chemical Testing in Food?

In a nutshell, chemical testing helps confirm the contents of the food you manufacture. It enables you to maintain the quality of your products, ensuring that they are safe. Chemistry testing aims to verify the food's chemical composition, such as how much sugar, protein, or fat it has. It also...

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