Issue of the Month
Regulatory insights from EAS Consulting Group consultants.
Each month, EAS Consulting Group publishes an Issue of the Month examining emerging regulatory developments, compliance challenges, and quality system insights across FDA-regulated industries.
These articles are written by EAS consultants and industry specialists with decades of experience supporting companies in food, dietary supplements, pharmaceuticals, medical devices, tobacco, and related sectors.
Topics frequently explored include food safety systems, inspection readiness, regulatory strategy, and emerging industry risks such as why food recalls are increasing.
New this month
Featured Insight
FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
Archive of Past Issue of the Month Regulatory Insights
How to Build an Achieving Team
By Eiman Raouf, EAS Senior...
Import Refusals – “Don’t Panic”
By Mark Moen, EAS Consulting...
Product Claim Substantiation
By Jay Ansell, EAS...
Quality Management System (QMS) Documentation
By Jeff VanderHoek, EAS...
Control of Cronobacter in Dairy Dryer and Packaging Rooms
By Beth Koenig, EAS...
Are You Ready for the Unspoken Challenges of FSMA 204?
By Norman Alayan, EAS...
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications
By Kevin Walls, MBA, EAS...
Shaping the Future: Revolutionizing Food Safety and Quality
By Vera K. Petrova...
Review of Food Safety Needs to Export from the USA
By Omar Oyarzabal PhD.,...
A Decade of Vigilance: FDA’s Battle Against Imported Foodborne Illness
By Don Abbott, EAS...
“Tree Nut” Allergy; Is It a Misnomer?
By Lisa Zitiello, EAS...
Status of Regulatory Compliance of Establishments Under USDA FSIS Jurisdiction
By Omar A. Oyarzabal, PhD,...
Biofilms and Healthcare
By David W Koenig, PhD., EAS...
The Food Safety Language
By Rafael Olivares, EAS...
FDA Proposes Long-Awaited Tobacco Product Manufacturing Practices
By Shelly Blackwell, Senior...
Claims Substantiation for Dietary Supplements: A Scientific and Legal Approach
By Paula Brock, Ph.D., MSCI,...
Developing a Food Safety Culture: Challenges and Best Practices
By Angie Surtani, EAS...
Process and Manufacturing Optimization to Minimize Inflation Impact on the Pharmaceutical Industry
By Ibrahim Khattab, EAS...
Importing: What Happens If Something Goes Wrong?
By Nick Lahey, EAS...
What Not To Feed Your Dog
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