EAS Consulting Group, LLC

An EAS Consulting Group Complimentary Webinar presented by Paula Vieira Brock, PhD, MSCI on September 9, 2024 Substantiation of product claims is required by law in the USA and this is not different for cosmetics. All types of claims need to be substantiated, from beautifying effects such as “reduces the appearance of wrinkles” to health-related claims such as “improves skin moisture”. The type of evidence used to substantiate the claims will depend on the claim. By discussing common claims, this free webinar will present different types of evidence and how to substantiate claims in cosmetic products. Register Now! https://hubs.ly/Q02NB-bY0

Maintaining the safety of the food we consume is complex and multi-faceted. Inspections and audits have become the backbone of our food industry’s quality control processes in preventing foodborne illnesses and ensuring the stringent regulatory measures are met. This article details the intricacies of the importance of inspections and audits, highlighting the procedure involved to reduce the consistency of recalls. Read More - https://hubs.ly/Q02NzwBZ0

USDA Releases Updated Guideline to Strengthen Substantiation of Animal-Raising and Environment-Related Claims on Meat and Poultry Labels WASHINGTON, August 28, 2024 – The U.S. Department of Agriculture (USDA) announced today the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry product labeling. Today’s action builds on the significant work USDA has already undertaken to protect consumers from false and misleading labels and to implement President Biden’s Executive Order on Promoting Competition in the American economy. “USDA continues to deliver on its commitment to fairness and choice for both farmers and consumers, and that means supporting transparency and high-quality standards,” said Agriculture Secretary Tom Vilsack. “These updates will help to level the playing field for businesses who are truthfully using these claims and ensure people can trust the labels when they purchase meat and poultry products.” Animal-raising claims, such as “Raised Without Antibiotics,” “Grass-Fed” and “Free-Range,” and environment-related claims, such as “Raised using Regenerative Agriculture Practices” and “Climate-Friendly,” are voluntary marketing claims that highlight certain aspects of how the source animals for meat and poultry products are raised or how the producer maintains or improves the land or otherwise implements environmentally sustainable practices. The documentation submitted by companies to support these claims is reviewed by USDA’s Food Safety and Inspection Service (FSIS) and the claims can only be included on the labels of meat and poultry products sold to consumers after they are approved by the agency. FSIS last updated its guideline on these claims in 2019. In the updated guideline, FSIS strongly encourages the use of third-party certification to substantiate animal-raising or environment-related claims. Third-party certification of animal-raising or environment-related claims helps ensure that such claims are truthful and not misleading by having an independent organization verify that their standards are being met on the farm for the raising of animals and for environmental stewardship. The revised guideline also emphasizes more robust documentation for environment-related and animal-raising claims. Additionally, the updated guideline recommends that establishments using “negative” antibiotic claims (e.g., “Raised Without Antibiotics” or “No Antibiotics Ever”) implement routine sampling and testing programs to detect antibiotic use in animals prior to slaughter or obtain third-party certification that includes testing. The revisions were informed by sampling data, petitions, public comments to those petitions and feedback received from a wide range of stakeholders. Read Full Release - https://hubs.ly/Q02N7QZd0

Football season is here! Keep your game day winning with USDA’s top tips to enjoy your tailgating feasts safely. 🏈 https://bit.ly/4g7vAHA

In an interview with Pharmaceutical Commerce Magazine Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, LLC, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA - Healthcare Distribution Alliance Traceability Seminar. https://hubs.ly/Q02N5bQL0

In these challenging times, the pharmaceutical industry remains crucial to U.S. consumers. Questions surrounding GMPs have never been more prevalent, prompting us to offer our Drug GMP Compliance Seminar in a virtual format. The EAS Consulting Group Drug GMP Seminar equips firms to meet FDA enforcement standards by clarifying the compliance requirements for domestic and international companies involved in the manufacture, labeling, packing, or holding of pharmaceuticals for sale in the U.S. market, as well as those engaged in drug testing, quality control, and distribution. Sign up today! - https://hubs.ly/Q02N3LTZ0

EAS Drug and Device Corner featuring Victoria Pankovich, Manager of Regulatory Services. Get the latest updates on regulatory matters for Drugs and Devices with our monthly update sent right to your inbox. https://hubs.ly/Q02MZXxZ0 [Subscribe] https://hubs.ly/Q02MZ_gH0 [View Current Edition]

An EAS Consulting Group Complimentary Webinar presented by Radhika Rajagopalan, Ph.D. on October 16, 2024 Proactive Planning for the Best Possible Outcomes FDA recent draft and final guidance documents related to generic drugs indicate the Agency’s thinking with regards to spurring competition with the aim of lowering the high cost of medicines. As such generic drug manufacturers have an opportunity to streamline their ANDA submission processes to better incorporate FDA’s safety and efficacy expectations to include labeling considerations and controlled correspondence. Being an early adopter of these improved practices will facilitate a timely review and increased the likelihood of approvals. Learn best practices for ANDA submissions with EAS Consulting Group and independent consultant and former FDA drug reviewer, Radhika Rajagopalan, Ph.D. She’ll discuss the recent guidance documents, distill what FDA is really looking for and how to best apply their principles to your submissions. Register - https://lnkd.in/euSaYrZr