EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
FDA Launches One-Day Inspectional Assessments to Expand Regulatory Oversight
FDA Introduces One-Day Inspectional Assessments The U.S. Food and Drug Administration has announced a new initiative called One-Day Inspectional Assessments, designed to expand oversight activities and improve the agency’s ability to evaluate regulated facilities more efficiently. According to...
FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA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.
USDA Announces Creation of Office of Seafood to Strengthen Industry Coordination
USDA Establishes Office of Seafood The U.S. Department of Agriculture has announced the creation of a new Office of Seafood, aimed at strengthening coordination, policy development, and support for the U.S. seafood industry. According to USDA, the new office will focus on improving collaboration...
FDA Warning Letter Cites AI Use in Pharmaceutical Manufacturing
The FDA has issued a warning letter citing the inappropriate use of artificial intelligence in pharmaceutical manufacturing, raising new concerns around cGMP compliance, data integrity, and oversight. This development signals increased regulatory scrutiny on how AI is implemented within quality systems and production processes.
Drug and Device Corner 2026 April
Reminder that the annual GDUFA self-ID submission period begins 1 May 2026. Submissions must be filed during the month of May. EAS can assist with this submission if needed. The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is...
FDA Releases Draft Guidance on Impurity Specifications for Antibiotics
The U.S. Food and Drug Administration has issued a draft guidance titled “Establishing Impurity Specifications for Antibiotics.” The guidance provides recommendations for manufacturers on establishing impurity limits for antibiotic drug substances and products, particularly those produced through...
FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey
The U.S. Food and Drug Administration has released its FY2025 sampling results focused on economically motivated adulteration (EMA) in honey. The sampling program is part of FDA’s ongoing efforts to detect food fraud and ensure the authenticity of products in the marketplace. Honey has...
Animal Food GRAS: Unpacking the Essentials
Presented by Dr. Adam Orr and Tim LombardoJune 17, 2026 | 3:00 PM ETThe U.S. is one of the most promising and expansive markets for innovative animal food ingredients. However, accessing the US requires knowledge about its regulatory requirements. Among the regulatory options, the Generally...
SQF Edition 10 Is Here: What It Means for Your Site and How to Prepare
The release of SQF Food Safety Code Edition 10 marks a significant evolution in how food safety systems are evaluated, managed, and audited. While updates to the SQF Code are expected, Edition 10 introduces structural, cultural, and digital changes that will directly impact how sites prepare for...
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: What Industry Needs to Know
Presented by Lisa El-Shall and Jeb HunterMay 8, 2026 | 2:00 PM ETWhen the FDA issues a Form 483 at the conclusion of a drug CGMP inspection, your response becomes a defining regulatory moment. How you address these observations can directly influence outcomes, including the risk of Warning Letters...
Overview of the Coming National Drug Code Format Change
Presented by Victoria PankovichMay 20, 2026 | 1:00 PM ETEAS Consulting Group is hosting a complimentary webinar, Overview of the Coming National Drug Code (NDC) Format Change. The FDA has finalized a rule establishing a uniform 12-digit National Drug Code format, replacing the current 10-digit...
International Equivalence: What Foreign Governments and Exporters Must Get Right to Access the U.S. Market
Accessing the U.S. market requires more than product compliance. Learn how the FSIS equivalence process works and where foreign inspection systems often fall short.
Drug and Device Corner 2026 March
2025 CARES reporting deadline is next Tuesday 31 March 2026!The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is a lengthy explanation describing how the agency arrived at the user fee amounts. The user fee due on 1 June 2026...
Responding to Food and Seafood FDA 483s
Presented by Mark Moen and Jeb HunterMay 19, 2026 | 2:00 PM ETWhen the FDA issues a Form 483 or Warning Letter, your response is critical—and time-sensitive. How you respond can directly impact regulatory outcomes, enforcement risk, and your firm’s credibility. This webinar will walk through FDA...
FDA to Host Public Meeting on the Scope of Dietary Supplement Ingredients
FDA Announces Public Meeting on Dietary Supplement Ingredient Scope The U.S. Food and Drug Administration will host a public meeting on March 27, 2026, focused on exploring the scope of dietary supplement ingredients under the Dietary Supplement Health and Education Act (DSHEA). The meeting will...
FDA Withdraws Temporary COVID FSMA Guidances Related to Onsite Audits
FDA Ends COVID-Era Flexibility for FSMA Onsite Audit Requirements The U.S. Food and Drug Administration has announced it is withdrawing two temporary guidances issued during the COVID-19 public health emergency related to onsite audit and verification requirements under the Food Safety...
FDA Announces New Steps to Streamline Biosimilar Development
FDA Takes Additional Steps to Support Biosimilar Development The U.S. Food and Drug Administration has announced new actions aimed at streamlining the development of biosimilar medicines and improving access to lower-cost biologic therapies. Biosimilars are biological products that are highly...
FDA Finalizes Rule Standardizing National Drug Code Format
FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements. The National Drug Code is a unique identifier assigned to drug products marketed in the...
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections
FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance provides recommendations for pharmaceutical manufacturers on...
FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope
FDA to Hold Public Meeting on Dietary Supplement Innovation and Ingredient Scope The U.S. Food and Drug Administration has announced an upcoming public meeting focused on dietary supplement innovation and the scope of dietary ingredients under the Dietary Supplement Health and Education Act...
Why Food Recalls Are Increasing — And What Companies Must Do Differently
Food recalls are increasing despite stronger regulations and expanded food safety systems. In this Issue of the Month, EAS consultant Amandeep Dhillon examines the systemic causes behind this trend and what companies must do differently to reduce risk.
EAS Expands Services: Biologics and Biosimilars Consulting
EAS Consulting Group is pleased to announce the expansion of our service offerings to include Biologics and Biosimilars regulatory and quality consulting. As these products continue to play an increasingly important role in the life sciences industry, organizations face complex challenges related...
FDA Expands Infant Formula Resources to Support Transparency and Access
FDA Enhances Resources Related to Infant Formula Oversight The U.S. Food and Drug Administration has announced updates to its infant formula resources aimed at improving transparency, safety, and access for consumers and stakeholders. The Agency stated that these enhancements are intended to...
California DTSC Proposes New Requirements for 1,4-Dioxane in Shampoos and Dish Detergents
The California Department of Toxic Substances Control (DTSC) is proposing to designate manual dish detergents and shampoos containing more than 1 ppm of 1,4-dioxane as “Priority Products” under the Safer Consumer Products program. If finalized, this designation would introduce new regulatory...
FDA Highlights Importance of Confidential Information in Maintaining Regulatory Integrity
FDA Emphasizes Role of Confidential Information in Its “Gold Standard” The U.S. Food and Drug Administration has published a new FDA Voices article highlighting the importance of protecting confidential information as a cornerstone of the Agency’s regulatory framework. The article explains how...
FDA Establishes Produce Regulatory Program Standards to Strengthen State Oversight
FDA Releases Produce Regulatory Program Standards (PRPS) The U.S. Food and Drug Administration has announced the establishment of Produce Regulatory Program Standards (PRPS), a new framework designed to strengthen and standardize produce safety oversight activities conducted by state programs. The...
Drug and Device Corner 2026 February
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported all NDC volumes. If you have...
Dietary Supplement Finished Product Testing and Specifications
The FDA requires that dietary supplement manufactures establish finished product specifications and test to ensure the specifications are met. However, the process of implementing this requirement is not always straightforward. What tests need to be included? Does every lot have to be tested? What if there is not a scientifically valid method available? This webinar will answer those questions and explain how to be compliant with the specification requirement for finished dietary supplement products.
FDA Announces New Actions Related to Food Traceability Rule Implementation
The U.S. Food and Drug Administration has announced several actions related to the implementation of the Food Traceability Rule, a key component of the Food Safety Modernization Act (FSMA) aimed at improving the ability to track and trace foods through the supply chain. The update provides...
FDA Initiates Review of BHA, a Common Food Preservative
The U.S. Food and Drug Administration has announced that it is launching a safety assessment of butylated hydroxyanisole (BHA), a synthetic antioxidant widely used in food products to prevent rancidity in fats and oils. BHA has been authorized for use in food for decades within established...