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.
What Not To Feed Your Dog
We love our dogs and puppies. They are faithful, non-judgmental companions who delight in our presence. Many pet owners return this affection by feeding them treats. But some human foods and household products are poisonous to dogs. Can we kill them with kindness?People Foods Versus Pet Foods...
Drug and Device Corner November 2022
Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without source NDC identification,...
How the Voluntary Qualified Importer Program (VQIP) Can Expedite Your US Imports
Most exporters of food products to the US are plagued by FDA import bottlenecks at the border. From paperwork to random and for-cause inspections, importing often feels like a waiting game. For everyone who has thought, Wouldn’t it be nice if FDA product imports could be expedited, this EAS Consulting Group, a Certified Group company, webinar discusses FDA’s “fast track” program for food imports called the Voluntary Qualified Importer Program (VQIP).
GDUFA III Targets New FDA Initiatives to Expedite Reviews and Inspections
FDA is pushing forward with new initiatives targeting enhancements to the Generic Drug User Fee Amendments (GDUFA) program as announced in a November 2021 commitment letter to industry. The current and third iteration of the GDUFA program, known as GDUFA III, enables FDA to continue assessing and...
Drug and Device Corner October 2022
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below.Federal Register Vol 87, No. 195...
Listeria monocytogenes in Ice Cream and Frozen Novelties
Ice cream is often associated with childhood, special occasions, and moments of pleasure with family and friends. Everyone has special ice cream memories! However, memories of eating ice cream should not be associated with illness, hospitalization, or death.
Dietary Supplement Product Development for Commercial and Compliance Success
Dietary supplement product development requires diligent product design, qualification and launch strategies that position your products ahead of the competition. Innovation is key in this high-stakes industry, as is staying in compliance with FDA expectations. This webinar offers tools for the...
Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Responding to an FDA Form 483 – Tips for Compliance Success
By Amy Scalin, M.S.Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will receive an FDA Form 483, or a...
EAS Welcomes Shelly Blackwell as Senior Director for Dietary Supplement and Tobacco Services
EAS Consulting Group is pleased to welcome Shelly Blackwell to the EAS management team. As Senior Director for Dietary Supplements and Tobacco, she will be responsible for overseeing safety, submissions, and general regulatory intelligence under the purview of FDA, USDA, FTC, and various state...
Developing Dietary Supplement Specifications – No “By Input” Here
Regulatory expert Steve Cammarn, Ph.D., discusses specifications testing for dietary supplement finished products. Use of “By Input” to verify the strength of a dietary ingredient or to exempt a finished product from testing is never acceptable.
The Role of Your US Agent
Foreign entities who operate in US FDA-regulated industries must have an appointed FDA US agent before they can import products into the US. At a minimum these FDA US agents provide the most basic of required services. However, agents with relevant experience and knowledge can provide much more.
Developing and Implementing a Supplier Qualification Program for Dietary Supplements
In this webinar, regulatory expert and EAS Independent Consultant Aisha Siddiqui explains what you need to know when developing a component supplier qualification program for dietary supplements.
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...
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...