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 Corner September 2022
As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops.EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent Advisor OTC Drugs and Labeling. We...
Listeria monocytogenes in Ice Cream and Frozen Novelties
An EAS and Food Safety News Complimentary Webinar. Presented by Kathy Knutson, Ph.D., EAS Independent Consultant. Tuesday, October 25, 2022 1:00 – 2:00 PM ETIce cream is often associated with childhood, special occasions, and moments of pleasure with family and friends. Everyone has special ice...
New York High Court Rejects Talc/Asbestos Causation Testimony, Reaffirming Need for Scientific Dose Assessment
By William A. Ruskin, EAS Independent Consultant and William L. Anderson, former partner at Crowell & MoringThis article is a revision of an article that first appeared in the Lexis Nexis publicationEditor's Note: Mr. Anderson is a former partner with Crowell & Moring LLP in Washington,...
Updates to Retail Program Standards Offers Flexibility
FDA recently released an updated 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) for both food service and food retail establishments. These standards give recommendations for designing, managing and reinforcing proper sanitation practices...
Drug and Device Corner August 2022
Reminder that the establishment registration and product listing renewal period begins 1 October 2022. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October, November, or December to be...
Certified Group Welcomes Amanda Bosse as CEO
CEO transition to strengthen and accelerate the company’s growth by driving innovation in the lab testing market and expanding production capacity to better serve customersSAN ANTONIO, Aug. 25, 2022 /PRNewswire/ – Certified Group, a leading provider of testing and regulatory consulting services in...
FDA Proposed Rule on Revising the National Drug Code Format
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted would require the addition of...
Certified Group Partners with Groundswell Strategy to Strengthen Their Position as Food Safety Experts
SAN ANTONIO, August 17, 2022/PRNewswire/ -- Certified Group, a leading provider of laboratory testing services for customers working in FDA and USDA-regulated markets, today announced a partnership with Groundswell Strategy. The partnership enables Certified Group companies, Food Safety Net...
Adverse Event Reporting for OTC Drug Products
By Susan Crane, EAS Senior Advisor for OTC Drugs and LabelingAs part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations established by the agency that...
Responding to an FDA Notice of Action
Timing is EverythingWhen importing FDA-regulated products into the U.S., time is money. So, when you receive an FDA Notice of Action, a prompt and appropriate response will expedite what comes next. Nearly 15% of U.S. imports are FDA-regulated products. That amounts to nearly $2.5 billion of goods...
Guidance for Industry: Enforcement Policy for Providing an Acceptable UFI
What You Need to Know EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility identifier (UFI) for every location registered with the agency as a food facility. The UFI is...
Drug and Device Corner July 2022
EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504.The FDA has finalized the UDI draft guidance document originally...
How to Get Microbiological Projects and Shelf-life Testing Done Easily
An extra day of shelf-life could save billions of dollars in wasted food. A 2014 study discovered that $2.64 billion could be saved annually if food waste could be reduced by giving products an extra day of shelf-life. The USDA also discovered in a 2010 study that 31% of the food produced annually...
FDA Expands Use of Remote Regulatory Assessments (RRA)
What You Need to KnowFDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part of a risk-based approach when...
Food Allergens and the FDA
An EAS and Food Safety News Complimentary Webinar. What’s Happening. Presented by Steve Gendel, EAS Independent Consultant. As we approach 20 years since the passage of the Food Allergen Control and Consumer Protection Act of 2004 (FALCPA), industry and the FDA continue to struggle with many...
EAS Welcomes Lisa El-Shall as Senior Director, Drug and Device Services
EAS Consulting Group is pleased to welcome Lisa El-Shall to the EAS management team. As Senior Director for Drug and Device Services, she will be responsible for advising clients on FDA regulatory and GMP compliance matters related to pharmaceutical and medical device products and operations. Lisa...
Drug and Device Corner June 2022
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or relabeled product will fail...
Environmental Monitoring Programs in Tablets and Capsules Magazine
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers assistance with design and...
Botanical Drugs: What Might the Future Hold?
By Brad Douglass, EAS Consulting Group Independent ConsultantThe Food and Drug Administration’s approval of Fulyzaq (crofelemer), an anti-diarrheal drug for HIV/AIDS patients, was a first for an oral, prescription botanical drug. Prior to that approval, the topical preparation Veregen...
What is Chemical Testing in Food?
In a nutshell, chemical testing helps confirm the contents of the food you manufacture. It enables you to maintain the quality of your products, ensuring that they are safe. Chemistry testing aims to verify the food's chemical composition, such as how much sugar, protein, or fat it has. It also...