Two years have passed since passage of the Generic Drug User Fee Act (GDUFA). GDUFA is a significant law that introduced new requirements for active pharmaceutical ingredient (API) manufacturers, including fees associated with their Type II drug master files (DMFs), as well as for establishment registrations and for conversion of type II DMFs into Electronic Common Technical… Read More
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).
Recent Issue of the Month Articles
Product recalls are a fact of life in the food industry. Recalls occurred an average of 12 times per week. Allergens remain the largest cause of recalls, due to mislabeling, cross-contamination or being undeclared. Large recalls of peanut products, eggs, ground beef and cantaloupe in recent years remind us of the potentially devastating impact of… Read More
Eight new sunscreen active ingredients have been awaiting approval—or any sort of decision—from the FDA for at least 12 years, with the last over-the-counter sunscreen ingredient approved by the agency in the 1990s. Meanwhile, some of these sunscreen ingredients have been available in Europe, Asia, or Latin America for more than 15 years. However, the… Read More
Recent Blog posts
Tobacco User Fees Now Payable to FDA
With the passage of the Tobacco Control Act User Fee Final Rule, 21 CFR Part 1150, domestic tobacco manufacturers as well as importers must now submit their required data for user fee assessment calculation, under the Federal Food, Drug, and Cosmetic Act, to the FDA beginning fiscal year 2015. Required information includes the number of… Read More
Food Facility Bi-annual Registration on-going!
FDA’s many new regulations to further strengthen the safety of the U.S. food supply under FSMA include the mandatory requirement for food facilities to register bi-annually. Those that do not register risk being “de-listed,” and thus unable to legally sell or import products in the U.S. Under FSMA, FDA also has the authority to audit… Read More
DQSA and a Myriad of New Regulations
With the enactment of the Drug Quality and Security Act, pharmacy compounders find themselves in a myriad of regulations that are not well understood within the practice of compounding pharmacy. Its difficult to establish processes and revise procedures to comply with GMPs. Outsourcing pharmacies will require many changes organizationally, training and a comprehensive mind set… Read More