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 April 2024
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics,...
Control of Cronobacter in Dairy Dryer and Packaging Rooms
By Beth Koenig, EAS Independent ConsultantWhat Is Cronobacter and Why Should We Be Concerned About It? Cronobacter, a genus of bacterial pathogens in the Enterobacteriacea family is of considerable concern in infant formula manufacturing and in the manufacture of products for populations with...
FY2024 OMUFA User Fees Announced by FDA
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics,...
FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on...
FDA Issues Import Alert for Food Products with Chemical Contaminants Including PFAS
On March 20, 2024, the US FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, gives the FDA...
FDA Launches Searchable Tobacco Products Database
Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally MarketedToday, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve...
Drug and Device March 2024
Reminder that CARES volume 2023 reports are due no later than 1 July 2024.Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug establishments in submitting...
Reassessment of EMPs
Reassessment of EMPs: Have You Identified the Correct Sampling Locations to Protect Your Product?An EAS Complimentary Webinar Presented by Rocelle Grabarek, EAS Independent ConsultantMarch 27, 2024 • 1pm (Eastern) 1.5 hoursMany of the environmental monitoring programs (EMP) have been established...
FDA Proposed Rule on “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs”
FDA proposes to revise the existing regulations regarding the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). These proposed regulations would...
USDA Finalizes Voluntary “Product of USA” Label Claim to Enhance Consumer Protection
USDA today published its “Product of USA” final rule, which will allow voluntary “Product of USA” or “Made in the USA” label claims to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the United States. Under the final...
Are You Ready for the Unspoken Challenges of FSMA 204?
By Norman Alayan, EAS Independent Consultant“The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability record-keeping requirements, beyond those in existing regulations, for persons who manufacture, process,...
FDA Announces Release of First Final Guidance Section for NDIN – NDI Notification Procedures and Timeframes
The FDA recently announced final guidance for industry on “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes.” This guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary...
Drug and Device February 2024
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for...
Media Spotlight: EAS Consultant John Bailey
John Bailey, an EAS consultant and the former director of FDA’s Office and Cosmetics and Colors, shared his thoughts with KFF Health News on FDA’s Plan to Ban Hair Relaxer Chemical Called Too Little, Too Late. Read...
FDA Issued a Final Guidance Document on CARES Act Reporting Requirements
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for...
FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance
The FDA has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry" (PCHF Draft Guidance). The changes address comments received on the drafts made...
Conducting Remote Regulatory Assessments Questions and Answers
FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, meet...
FDA Issues Final QMSR Regulation and FAQ
The Food and Drug Administration (FDA) issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation defined in 21 CFR Part 820 to harmonize and modernize the regulation. The reason for the change...
FDA Issues Revised Draft Guidance for Topical Ophthalmic Drug Products
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance specifically notes recent cases of...
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications
By Kevin Walls, MBA, EAS Independent Consultant The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are incorporating into their quality system. The US Food and Drug Administration (FDA), Health Canada, Brazil Agência Nacional de Vigilância...