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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.

Top Five Considerations for Pre-Submissions

Top Five Considerations for Pre-Submissions

By Elvira Cawthon, EAS Independent Consultant Premarket submissions for medical devices are costly, time-consuming, and denial of a submission can be devastating. Though the FDA Q-Submission (Q-Sub) Program, designed to minimize risk by enabling Sponsors and Manufacturers the opportunity to attain...

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Safe Foods for Canadians – What you Need to Know

Safe Foods for Canadians – What you Need to Know

The Canadian Food Inspection Agency (CFIA) is responsible for the safety of food products sold in Canada by enforcing the recently implemented Safe Foods for Canadians Regulation (SFCR). It is a compilation of 14 sets of regulations governing safety of human …

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USDA Regulatory Requirements for Food Safety

USDA Regulatory Requirements for Food Safety

Instructor EAS Independent Consultant Armia Tawadrous, DVM A 12-hour seminar in three-parts, taking place June 14, 16, 18, 2021 From 11am-3pm eastern each day  The sensitivity of meat and poultry products to microorganism contamination by bacteria, viruses and parasites renders them an...

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Did You Know? Biopesticide Registration is Required by the EPA

Did You Know? Biopesticide Registration is Required by the EPA

Derived from natural materials, biopesticides, are inherently less toxic than conventional pesticides and when used as a component of Integrated Pest Management (IPM) programs, can greatly reduce conventional pesticide use and improve crop yields. EPA has regulatory authority over biopesticides as...

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Cosmetic Regulations, Labeling and Safety Virtual Seminar

Cosmetic Regulations, Labeling and Safety Virtual Seminar

How to Ensure Your Products Comply with the US RequirementsInstructors EAS Independent Advisor for Colors and Cosmetics, John Bailey, Ph.D. & EAS Independent Consultant, Catherine BaileyOctober 27, 2022 - 11:00am-3:00pm easternCosmetic products are expected to only exert superficial, not...

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Is your CMO Aware of Their FDA Obligation for OTC-Drug User Fees?

Is your CMO Aware of Their FDA Obligation for OTC-Drug User Fees?

Last week FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice. Under the new 2021 rates: Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $14,060. Owners of a contract manufacturing facility will...

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Recall Plans and Strategies

Recall Plans and Strategies

Robert Fish, Independent Advisor, Quality and Compliance Every year FDA monitors thousands of recalls of regulated products (over 7,000/year). Though most product recalls are voluntary, the FDA can also order them. Recalls can be very damaging to the reputation of a company and its brands....

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The Cosmetic-Drug Conundrum

The Cosmetic-Drug Conundrum

The subtle differences between allowable cosmetics claims and those crossing the line into drug products is tricky. The wrong claims can cause a cosmetic product to be misbranded attracting unwanted FDA attention. Once some of your marketing claims are under review, you can expect a closer...

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US FDA Proposed Traceability Rule – Overview

US FDA Proposed Traceability Rule – Overview

FDA’s proposed rule “Requirements for Additional Traceability Records for Certain Foods” mandates traceability recordkeeping requirements for certain foods such as cheeses, shell eggs, some types of fish and produce. When finalized, the Traceability Regulation will be …

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Did You Know? Medical Foods and FDA – Regulatory Scrutiny Ahead

Did You Know? Medical Foods and FDA – Regulatory Scrutiny Ahead

A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.” This means that medical foods are not those simply...

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Drug and Device Corner February 2021

Drug and Device Corner February 2021

CDER's Work to Meet User Fee Goals During the Pandemic website includes an overview of the agency’s thinking regarding manufacturing facility inspections during the age of COVID-19. As always, the FDA will use a risk-based approach to identify facilities that require pre-approval inspection for...

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USDA Labeling Compliance Virtual Seminar

USDA Labeling Compliance Virtual Seminar

Instructor EAS Independent Consultant Susan GlennApril 5-6, 2022 12pm-3pm eastern each dayIf you develop USDA-regulated products you need to understand USDA labeling requirements. USDA labeling has its own set of allowable product names, claims and nutrition labeling requirements. EAS Consulting...

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Drug and Device Corner January 2021

Drug and Device Corner January 2021

EAS Client UpdatesBreaking News: FDA Places All Alcohol-Based Hand Sanitizers from Mexico on Import Alert As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand...

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Streamline Food Exports to the US

Streamline Food Exports to the US

Six Steps to Compliance SuccessEnsuring compliance with FDA’s Food Safety Modernization Act (FSMA) can be confusing, particularly for foreign-based companies trying to comply with the additional traceability requirements of FSMA’s Foreign Supplier Verification Program (FSVP). Did you know that EAS...

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FDA Withdrawal Announcement

FDA Withdrawal Announcement

The FDA published today in the Federal Register Vol. 86, No. 3 a withdrawal of their December 29, 2020 Federal Register Notice entitled Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021./p> With the FDA’s most recent announcement, the agency is informing the...

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Wishing You a Healthy and Happy 2021

Wishing You a Healthy and Happy 2021

From our family to yours, EAS Consulting Group wishes everyone a healthy and happy New Year! 2020 will certainly be remembered as one of immense challenges and creative opportunities. From the push to develop effective testing and vaccines, to supply chain issues that upended manufacturing and...

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FDA OTC-Drug User Fee Rates Established for FY 2021

FDA OTC-Drug User Fee Rates Established for FY 2021

FDA announced the fiscal year 2021 OTC-Drug User Fee rates in a Federal Register Notice published today, 12/29/2020. The notice covers all qualifying manufacturers and processors of finished dosage form OTC monograph drugs, including contract manufacturing facilities and submitters of OTC...

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Micro Quality Labs Joins the Certified Group Family

Micro Quality Labs Joins the Certified Group Family

We are proud and excited to announce that Micro Quality Labs (MQL) has joined the Certified Laboratory family of companies. MQL is an ISO accredited, independent analytical testing laboratory, providing state-of-the-art instrumental chemical and microbiological analyses to the cosmetic, skincare,...

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Drug and Device Corner November 2020

Drug and Device Corner November 2020

Revisions to section 801(e)(4)(E)(iii) of the FD&C Act as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act direct FDA to provide certification for Devices Not Exported from the U.S. Manufacturers of devices not exported from the United States, as described in section...

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