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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.

Considerations for Complying with 21 CFR 211.110

Considerations for Complying with 21 CFR 211.110

January 2025 Docket Number: FDA-2024-D-5374 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary MedicineThis guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure...

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Pet Supplement Industry on the Rise

Pet Supplement Industry on the Rise

Recent survey reports indicate that supplements for pets have reached US sales of nearly $3 billion, with dog and cat supplements comprising of approximately 75% and 20% of the total, respectively. The growing pet supplement market is aimed at pet health and wellness, particularly for issues like mobility, skin and coat health, and anxiety. Survey reports specifically indicate that hip and joint supplements are the most frequently type of supplement purchased.

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Claims Substantiation Seminar

Claims Substantiation Seminar

This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.

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Drug and Device Corner December 2024

Drug and Device Corner December 2024

The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user completes an ACNU...

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FDA Submits Proposal to Set a Nicotine Limit on Tobacco Products

FDA Submits Proposal to Set a Nicotine Limit on Tobacco Products

The U.S. Food and Drug Administration has submitted a proposal to the Office of Management and Budget (OMB) to limit the amount of nicotine in tobacco products, reports CNN. “A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain...

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VQIP Application Portal Opens for FY2026

VQIP Application Portal Opens for FY2026

Constituent Update December 10, 2024 Read on FDA site  On January 1, 2025, the U.S. Food and Drug Administration (FDA) will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2026. VQIP is a voluntary fee-based program that provides importers, who...

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Drug and Device November 2024

Drug and Device November 2024

This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024.  If you need help with your submissions, please reach out to EAS for support....

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Health Canada

Health Canada

Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.

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Are You as an Importer Ready for FSMA Traceability Rule?

Are You as an Importer Ready for FSMA Traceability Rule?

By Angel Suarez, EAS Consulting Group Independent ConsultantUnder the Food Safety Modernization Act (FSMA) the FDA has finalized several major rules to ensure the safety of the food supply is a shared responsibility across the global supply chain. The last of these major rules is the FDA Food...

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Human Food Program (HFP) FY 2025 Priority Deliverables

Human Food Program (HFP) FY 2025 Priority Deliverables

On this page: Introduction FY 2025 Priority Deliverables About the Human Foods ProgramIntroduction The FDA is responsible for regulating 80% of the U.S. food supply, with the Human Foods Program (HFP) overseeing all activities related to food safety and nutrition. The FDA launched the HFP as part...

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FDA Releases Supplement to the 2022 Food Code

FDA Releases Supplement to the 2022 Food Code

The U.S. Food and Drug Administration (FDA) today has published the Supplement to the 2022 Food Code. The Supplement updates the 2022 Food Code with recommendations made by regulatory officials, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection. ...

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Drug and Device October 2024

Drug and Device October 2024

Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact Victoria Pankovich at EAS. The...

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Good ANDA Submission Practices

Good ANDA Submission Practices

Proactive Planning for the Best Possible OutcomesPresented by Radhika Rajagopalan, Ph.D., EAS Independent ConsultantFDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to spurring competition with the aim of lowering the high cost of...

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Food Traceability Rule (FSMA 204)

Food Traceability Rule (FSMA 204)

Coming Soon!The FDA Food Safety Modernization Act (FSMA), enacted in 2011, empowers the FDA to bolster public health by strengthening the food safety system through new regulatory actions. FSMA is the compilation of many FDA food regulations, encompassing stringent rules for food production,...

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CVM GFI #294 – Animal Food Ingredient Consultation (AFIC)

CVM GFI #294 – Animal Food Ingredient Consultation (AFIC)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food. Since 1920, the Association of...

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Important Changes to OTC Monograph Listing Marketing Categories

Important Changes to OTC Monograph Listing Marketing Categories

In addition to a reminder of the Drug Establishment Registration Renewal period (1 October – 31 December) EAS would like to remind you of significant changes being implemented for OTC monograph drug product listings. The changes were announced by FDA last year and reminders were included in EAS’...

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