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
USDA’s Process for Auditing Equivalent Foreign Food Safety Systems
This Issue of the Month explains how the USDA evaluates and audits foreign food safety systems for equivalence, outlining the review process and what exporting countries and food producers should understand when seeking access to U.S. markets.
Archive of Past Issue of the Month Regulatory Insights
Why Submit GRAS Notification for a Dietary Ingredient?
By James Hoadley, Ph.D., EAS...
FDA Has Higher Expectations for Generic Drug Applications
By Charles “Chris” Celeste,...
The Top Ten Reasons for FDA Warning Letters to Medical Device Firms
By EAS Director of...
FDA’s Proposed Rule on Antibacterial Soaps
By EAS Senior Consultant...
Distinguishing Medical Device Recalls
By EAS Senior Consultant...
Regulatory Options for Food Ingredients in the U.S.
By EAS Senior Advisor for...
ISO/IEC 17025:2005 and the Benefits of Accreditation
By EAS Senior Consultant Bob...