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.
Upcoming FDA Food Guidance Materials for 2024
On January 25, 2024, the U.S. Food and Drug Administration’s Foods Program posted a list of new / updated food regulations it plans to publish in 2024 and beyond. These include:Amendments to Registration of Food Facilities February 2024. The proposed rule would make clarifying changes to general...
FDA Announces Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Drug Products
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation on Harmonisation of Technical...
Cosmetic Safety Substantiation
Presented by Paula Brock, Ph.D., MCSI, EAS Senior Regulatory ConsultantFebruary 22, 2024 1:00 - 3:00 (Eastern)The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) became effective in December 2023 and includes a requirement for safety substantiation. MoCRA is an amendment to the Federal...
Shaping the Future: Revolutionizing Food Safety and Quality
By Vera K. Petrova Dickinson, EAS Independent ConsultantIn the ever-evolving landscape of the food industry, the quest for ensuring Food Safety and Quality (FSQ) faces both new challenges and age-old dilemmas. As we navigate this intricate space, it becomes increasingly evident that the current...
Drug and Device December 2023
With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program –...
FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is required to report serious adverse...
FDA Announces Availability of Draft Supplemental Guidance on Menu Labeling
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled Menu Labeling: Supplemental Guidance for Industry (Edition 2). To respond to frequently asked questions regarding menu labeling requirements, the draft guidance, once finalized,...
Drug and Device November 2023
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be updated and submitted to...
FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
Today, the U.S. Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure...
21 CFR Part 11 and FDA Compliance
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA ComplianceAn EAS Complimentary Webinar Presented by Carolyn Troiano, EAS Independent ConsultantNovember 8, 2023 • 1:00 pm – 4:00 pm (ET); 3 HoursEnter Your Information to Watch NowBy clicking submit above, you consent to allow EAS Consulting Group...
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
FDA has issued a Draft Guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities”. Comments may be made to Docket number FDA-2023-D-4416 by 26 December 2023. This draft guidance describes how the FDA will request and conduct voluntary remote interactive...
Review of Food Safety Needs to Export from the USA
By Omar Oyarzabal PhD., Senior Consultant for Food ServicesExporting foods from the USA to other countries, such as Canada and those in the EU block, has been a lucrative option for some segments of the food industry. This short article reviews some or the current trade with the European Union...
MoCRA: Facility Registration and Product Listing for Cosmetics
The Clock is Ticking: Are you Ready for Facility Registration and Product Listing under MoCRA?An EAS Complimentary Webinar Presented by John and Catherine Bailey, EAS Independent Consultants and Victoria Pankovich, Manager of Regulatory ServicesOctober 30, 2023 • 12pm (Eastern) 1 hourThe new...
Drug and Device October 2023
The FDA published a new Guidance Document - Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications which articulates the agency’s evolving policy which has grown from the Pandemic era use of alternative tools in evaluating drug manufacturing facilities...
MoCRA Preparations Should be in Progress
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. For facilities that need to register [every person who...
A Decade of Vigilance: FDA’s Battle Against Imported Foodborne Illness
By Don Abbott, EAS Independent ConsultantIntroduction Over the past decade, the Food and Drug Administration (FDA), particularly its Center for Food Safety and Applied Nutrition (CFSAN), has been at the forefront of safeguarding the American public against foodborne illnesses originating from...
The FDA Has Updated the Food Traceability Frequently Asked Questions on the Website
On September 28, 2023, the U.S. Food and Drug Administration (FDA) has updated its Food Traceability Frequently Asked Questions (FAQ) to provide additional information about this rule. The Food Traceability Final Rule was published in November 2022 and requires the implementation of traceability...
FDA Issues New Guidance for Allergen Management and Control
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include: Establish and Implement a Food Allergen Program. The...
Drug and Device September 2023
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline deems any generic drugs...
FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the process. In addition to the guidance...