Specializing in FDA Regulatory Matters

EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.

 

Headquartered in Alexandria, VA with consultants and auditors located strategically throughout the U.S., EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).

Why Submit a GRAS Notification for a Dietary Ingredient?

A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the United States as a dietary supplement ingredient before October 15, 1994. Manufacturers of NDI-containing dietary supplements must notify FDA of their intent to market a NDI-containing supplement at least 75 days before the supplement is marketed in the U.S. The… Read More

Proposed Changes in Nutrition Labeling – Time to Make Your Comments

In March, FDA published proposals for changes to Nutrition Facts and Supplement Facts. The proposed changes include reformatting of all conventional food labels in the servings per container and calorie declarations. The specifics of the new format may change a little based on information in comments, but it is likely that the basic approach of… Read More

FDA Has Higher Expectations for Generic Drug Applications

FDA expects industry to begin submitting higher-quality applications to facilitate expedited reviews and approvals of generic drugs, agency officials explained at the Generic Drug User Fee Amendment (GDUFA) and You Conference in Lake Buena Vista, FL, March 27-28. The goal of the meeting — which was hosted by the Office of Small Business and Industry Assistance (SBIA)… Read More

The Top Ten Reasons for FDA Warning Letters to Medical Device Firms

Since December 1978, medical device manufacturers have been subject to FDA regulations and inspections based on the Good Manufacturing Practices (GMP) requirements. On June 1, 1997 FDA amended the 1978 regulations to include quality system regulations (QSR). An FDA “Warning Letter” is considered by the agency to be the first step in the enforcement process… Read More

Medical Device

FDA Proposes Revised Nutrition Labels on Foods (and Some Dietary Supplements)

FDA announced on February 27, and published in the March 3 Federal Register, proposals to revise the Nutrition Facts label. This is the first time in the 20 years of the Nutrition Facts label that FDA is making major revisions. The proposed revisions incorporate updated information on advice for healthy dietary practices and food consumption patterns… Read More