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.
U.S. FDA’s Latest Requirements for the 510(k)
Presented by John Lincoln, EAS Independent Consultant. The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds...
Good Auditing Practices, Making the Most of Your Internal Review
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
Understaffed Restaurants and the Risk of Foodborne Illness
By Jayne Roth, M.P.H, REHS, EAS Independent Consultant At the end of 2021, a survey fielded by the National Restaurant Association, showed that 78% of operators said their restaurant did not have enough employees to support customer demand. Understaffing is not only an economic issue, but also a...
FDA Takes OTC Accelerated Stability Data Very Seriously
Did You Know?The FDA expects all drug products to bear an expiration date that is backed by scientifically sound data and projections, regardless of whether that drug is an NDA, ANDA or Over the Counter (OTC) monograph product. Under the FDA’s current expectations, OTC monograph drugs are provided...
The 12-Steps of Operational Efficiency
How Aligning of Operations and Quality Assurance Can Drive Down Costs While Improving Efficiency. Presented by Mike Hughes and Steve Cammarn, Ph.D., EAS Independent Consultants. Operations and Quality Assurance departments often operate in opposition. Their different goals lead to different...
Drug and Device Corner March 2022
FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June 2022 Regarding fee specifics,...
Selecting a CRO – an Important Consideration on the Path to Determining GRAS for a Food Ingredient
By Shawna Lemke, EAS Independent ConsultantThe noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In the US, concerns about...
FSPCA Preventive Controls for Human Foods, Part 2 of Blended Course
Presented by Omar Oyarzabal, Ph.D. Senior Consultant. June 13-14, 2022 from 1-5pm easternThis course is for food manufacturers that need to complete Part 2 of the Blended Class on Preventive Control for Human Food. This online class will be delivered in two days of live, video conferences, from 1...
Medical Device Product Risk Management
Presented by John Lincoln, EAS Independent Consultant. Both the U.S. FDA and the EU's MDR require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits though many are still not developing...
Navigating the Process of Importing Food Products into the United States
Presented by EAS, Certified Laboratories and L&L Trade Law. Importers of food products intended for introduction into the U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. Importers can import foods into the...
Drug and Device Corner February 2022
FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO 13485:2016, Medical devices –...
Are We Even on the Same Team?
Aligning Operations and Quality Drives Down Costs While Improving Efficiency By Mike Hughes, EAS Independent ConsultantHave you ever felt like your co-workers are at a different company? Maybe, even a competitor who is trying to run you out of business? Yup – I have. I am an Operations guy and the...
How To Be an Effective and Sought After Expert Witness
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony...
Blended Learning – Part of a Culture of Learning
By Nancy Higley, EAS Independent Consultant Continuous learning supports both business and employee goals. When you hire an employee, you are hiring an asset capable of continuous growth. An educated professional can be a point of difference for your business. There is no one solution for Learning...
EAS Consulting Provides Keynote Address at AFIA
EAS consultant Carolyn Kennedy provided the keynote address at the American Feed Industry Association (AFIA) conference during the International Production and Processing Expo (IPPE) in Atlanta. Speaking on human grade pet food, she discussed submissions, labeling, and the future of the industry....
Drug and Device Corner January 2022
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD submissions via ESG, please...
EAS Announces Omar Oyarzabal, Ph.D. as the New Senior Consultant for Food Services
EAS is pleased to announce Omar Oyarzabal, Ph.D. as a new senior consultant for Food Consulting Services. Dr. Oyarzabal, a long-time consultant with EAS, begins this new role today. As a senior consultant, he will work directly with EAS’ Senior Director for Food Consulting Services to assure...
Roles and Responsibilities for Ensuring the Safety of Animal Food
By Johnny Braddy, DVM, MPH, Dipl. ACVPM, EAS Independent Consultant. (This Issue of the Month article is an abbreviated version of a White Paper published on the EAS website.). To help ensure that the nation’s food supply is safe, Congress amended the Food Drug & Cosmetic Act (FD&C)...
Roles and Responsibilities for Ensuring the Safety of Animal Food
Prepared by Johnny Braddy, DVM, MPH, DACVPM, EAS Independent ConsultantDecember 2021
Drug and Device Corner December 2021
REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 Cover Letter Attachments for Controlled Correspondences and ANDA...
FDA Issues Draft Guidance on Validation and Verification of Analytical Testing Methods Used for Tobacco Products
On Dec. 21, FDA issued draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test...
FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). This LAAF program recognizes accreditation bodies that accredit food testing laboratories...
Preparing for TMPs
Are You Ready for TPMPs? Contact EAS for assistance with all of your regulatory needs. Download our quick reference service information sheet or visit our Tobacco services page for more detailed information on how we can help you.
Dairy Processing 101
A Virtual Training Presented by EAS Consulting GroupPresented by EAS Independent Consultants, Allen Sayler, Gabe Miller, Dave Blomquist, and Rhaisa A. Crespo, Ph.D.February 15, 17, 22 & 24, 2022From 12:00pm-3pm eastern each dayThe FDA’s Food Safety Modernization ACT (FSMA) and Safe Quality...
Titanium Dioxide – What the EU Ban Means For You
By April Kates, EAS Independent Consultant What is Titanium Dioxide? Titanium dioxide is a substance that has regulatory status in the US for many uses, including as a food additive. In 1966, It was approved to be used in foods at up to 1 percent by weight as a color additive. As a coloring agent,...
Drug and Device Corner November 2021
Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website for support. Clients wishing to...
Amazon Offers New Documentation Flexibility for Dietary Supplement Selling Partners
Amazon recently announced flexibility for selling partners to demonstrate of Good Manufacturing Practices (GMPs) for dietary supplements. The new policy requires submission of three demonstrations of quality, two of which are mandatory. The third requirement provides flexibility, with two options...
Dietary Supplement Good Manufacturing Practices (GMP) for Laboratories
Ensuring Regulatory CompliancePresented by Charlotte Peyton, Independent ConsultantMarch 1 & 3, 2022, from 12-4:30 pm eastern each dayEAS is offering an intensive virtual seminar covering FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality...
Regulatory Considerations for Novel Sports Nutrition Products and Ingredients
By EAS Independent Consultant, David Cockram, PhD Nearly every athlete wants something extra that will provide them with an edge over the competition. Optimizing nutrition is certainly a huge part of improving athletic performance. A well-balanced diet, with appropriate levels of carbohydrates,...
Drug and Device Corner October 2021
REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based Hand Sanitizers. With a thank...