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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 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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Health Canada

Health Canada

Presented by Paula Brock, Ph.D., MCSI, Senior Regulatory & Scientific ConsultantNovember 14, 2024 at 11:30am - 12:30pm easternInterested 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...

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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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Investigating Pesticide Tolerance

Investigating Pesticide Tolerance

By Dr. Bill Reeves, EAS Regulatory ConsultantConsistent, scientifically justified regulations enable over $1.5 trillion in global agricultural exports every year. The world economy depends on these regulations to ensure whatever goes onto a ship is legal to sell when it reaches port. One key...

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FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024

FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024

Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1...

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FY2025 Drug Program User Fees

FY2025 Drug Program User Fees

Please see below information regarding FY2025 Drug Program User Fees which go into effect 1 October 2024. The FDA has announced FY2025 user fees for GDUFA, OMUFA (Order Requests only), PDUFA, BsUFA, and animal user fee programs. Please see the Federal Register notices for details on each. FR Vol....

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Claims Substantiation of Cosmetic Products

Claims Substantiation of Cosmetic Products

An EAS Consulting Group Complimentary On Demand WebinarPresented by Paula Brock, Ph.D., MCSISeptember 9, 2024 • 11:30 AM (Eastern) • Length: 45 minutesSubstantiation of product claims is required by law in the USA and this is not different for cosmetics. All types of claims need to be...

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