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
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...
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...
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...
USA Workshop: Correct labeling is half the battle
Gisela Leon, EAS Consulting Group Independent ConsultantInterviewed for Industrie- und Handelskammer HannoverOctober 15, 2024Published in GermanThere are easily 100,000 nutritional supplements on the market in the USA. 1,000 to 1,500 new products are introduced every year - vitamins, minerals,...
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...
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’...
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...
Drug and Device September 2024
The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate. Any NDC SPL file requiring updates should be done prior to 31 December 2024. The marketing...
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...
Importing FDA-Regulated Seafood Products – New FDA Video Now Available
The U.S. Food and Drug Administration (FDA) has released the third video in the “Importing FDA-Regulated Products” series. This new video provides an overview of the process for importing seafood, focusing on key regulatory requirements. It is designed to help importers, brokers, and foreign...
New Webinar: Preparing and Submitting a Standalone Pre-Existing Tobacco Product Submission
CTP invites you to watch the tobacco compliance webinar, "Pre-Existing Tobacco Product Determination Program Webinar Series Part 2 of 3: Preparing and Submitting a Standalone Pre-Existing Submission.” This webinar is part two of a three-part webinar series providing details on various topics...
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...
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....
FY2025 Medical Device Fees
Please see below information regarding FY2025 Medical Device User Fees which go into effect 1 October 2024. Keep in mind, the FY2025 facility user fee must be paid prior to processing your annual renewal during the renewal period Oct 1 – Dec 31. FY2025 Medical Device facility registration user...
Product Imports Into the U.S That Contain Meat and Poultry: Maneuvering the Process?
By Ronnie Dunn, EAS Consulting Group Independent ConsultantImporting meat, poultry, and egg products into the U.S. can be a daunting and confusing task. There are numerous regulations and processes that must be followed spanning many U.S. government agencies. Much research needs to be done prior...
AHPA Claims Substantiation Tools and Trends
AHPA Claims Substantiation Tools and TrendsPresented by Paula Brock, Ph.D., MCSIThis is a portion of a webinar produced by the American Herbal Products Association (AHPA) originally held July 9, 2024.Enter Your Information to Watch NowBy clicking submit above, you consent to allow EAS Consulting...
Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role.
Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role. by Don Abbott, EAS Consulting Group Independent Consultant Published in Food Safety Tech
USDA Releases Updated Guideline to Strengthen Substantiation of Animal-Raising and Environment-Related Claims on Meat and Poultry Labels
WASHINGTON, August 28, 2024 – The U.S. Department of Agriculture (USDA) announced today the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling. Today’s action...
HDA 2024 Traceability Seminar: What to Expect From FDA Inspections
In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.
Drug and Device August 2024
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the labeling of OTC internal...