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.
Drug and Device Corner October 2022
As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below.Federal Register Vol 87, No. 195...
Listeria monocytogenes in Ice Cream and Frozen Novelties
Ice cream is often associated with childhood, special occasions, and moments of pleasure with family and friends. Everyone has special ice cream memories! However, memories of eating ice cream should not be associated with illness, hospitalization, or death.
Dietary Supplement Product Development for Commercial and Compliance Success
Dietary supplement product development requires diligent product design, qualification and launch strategies that position your products ahead of the competition. Innovation is key in this high-stakes industry, as is staying in compliance with FDA expectations. This webinar offers tools for the...
Establishing an Effective Environmental Monitoring Program
Prevention of product contamination through an Environmental Monitoring Program is a requirement across FDA regulated industries. This ensures product safety and reduces the likelihood of an adverse event(s) for the consumer. An established EMP is required by FDA as part of a Good Manufacturing Practice (GMP) quality system.
Responding to an FDA Form 483 – Tips for Compliance Success
By Amy Scalin, M.S.Hearing from FDA often means one thing: The Agency has found issues with your operations that require a swift response and corrective actions. FDA uses numerous tools to notify firms of regulatory compliance enforcement. Most commonly, a firm will receive an FDA Form 483, or a...
EAS Welcomes Shelly Blackwell as Senior Director for Dietary Supplement and Tobacco Services
EAS Consulting Group is pleased to welcome Shelly Blackwell to the EAS management team. As Senior Director for Dietary Supplements and Tobacco, she will be responsible for overseeing safety, submissions, and general regulatory intelligence under the purview of FDA, USDA, FTC, and various state...
Developing Dietary Supplement Specifications – No “By Input” Here
Regulatory expert Steve Cammarn, Ph.D., discusses specifications testing for dietary supplement finished products. Use of “By Input” to verify the strength of a dietary ingredient or to exempt a finished product from testing is never acceptable.
Developing and Implementing a Supplier Qualification Program for Dietary Supplements
In this webinar, regulatory expert and EAS Independent Consultant Aisha Siddiqui explains what you need to know when developing a component supplier qualification program for dietary supplements.
Drug and Device Corner September 2022
As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops.EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent Advisor OTC Drugs and Labeling. We...
New York High Court Rejects Talc/Asbestos Causation Testimony, Reaffirming Need for Scientific Dose Assessment
By William A. Ruskin, EAS Independent Consultant and William L. Anderson, former partner at Crowell & MoringThis article is a revision of an article that first appeared in the Lexis Nexis publicationEditor's Note: Mr. Anderson is a former partner with Crowell & Moring LLP in Washington,...
Updates to Retail Program Standards Offers Flexibility
FDA recently released an updated 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) for both food service and food retail establishments. These standards give recommendations for designing, managing and reinforcing proper sanitation practices...
Drug and Device Corner August 2022
Reminder that the establishment registration and product listing renewal period begins 1 October 2022. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October, November, or December to be...
FDA Proposed Rule on Revising the National Drug Code Format
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted would require the addition of...
Adverse Event Reporting for OTC Drug Products
By Susan Crane, EAS Senior Advisor for OTC Drugs and LabelingAs part of its mission to protect the public health, the FDA monitors the safety of drug products marketed in the United States. This is accomplished through laws enacted by Congress as well as regulations established by the agency that...
Responding to an FDA Notice of Action
Timing is EverythingWhen importing FDA-regulated products into the U.S., time is money. So, when you receive an FDA Notice of Action, a prompt and appropriate response will expedite what comes next. Nearly 15% of U.S. imports are FDA-regulated products. That amounts to nearly $2.5 billion of goods...
Guidance for Industry: Enforcement Policy for Providing an Acceptable UFI
What You Need to Know EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility identifier (UFI) for every location registered with the agency as a food facility. The UFI is...
Drug and Device Corner July 2022
EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504.The FDA has finalized the UDI draft guidance document originally...
FDA Expands Use of Remote Regulatory Assessments (RRA)
What You Need to KnowFDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part of a risk-based approach when...
Food Allergens and the FDA
Food Allergens, Contamination Risks, and the FDARegulatory expert Steven Gendel discusses the many struggles of implementing an effective allergen control system. Nearly 20 years since the passage of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the misbranding of...
EAS Welcomes Lisa El-Shall as Senior Director, Drug and Device Services
EAS Consulting Group is pleased to welcome Lisa El-Shall to the EAS management team. As Senior Director for Drug and Device Services, she will be responsible for advising clients on FDA regulatory and GMP compliance matters related to pharmaceutical and medical device products and operations. Lisa...
Drug and Device Corner June 2022
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or relabeled product will fail...
Botanical Drugs: What Might the Future Hold?
By Brad Douglass, EAS Consulting Group Independent ConsultantThe Food and Drug Administration’s approval of Fulyzaq (crofelemer), an anti-diarrheal drug for HIV/AIDS patients, was a first for an oral, prescription botanical drug. Prior to that approval, the topical preparation Veregen...
EAS and Labstat Welcome New Incoming CTP Director, Brian A. King, Ph.D., M.P.H.
FDA’s Center for Tobacco Products (CTP) has announced the selection of a new CTP director, Brian A. King, Ph.D., M.P.H. Dr. King previously worked at the Centers for Disease Control and Prevention’s Office on Smoking and Health. Dr. King is charged with furthering CTP’s efforts to improve the...
How Would FDA’s Dietary Supplement Listing Act of 2022 Impact Your Business?
A bill before U.S. Congress proposes a new requirement that all dietary supplement products be electronically listed with Secretary of Health and Human Services. This move will enable the creation of a publicly available on-line registry in support of consumer decision making and to provide FDA...
Drug and Device Corner May 2022
The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to assist stakeholders in developing a...
Assume Nothing: What You Think You Know About the Cannabis Industry May Not Be True
An EAS and Food Safety News Complimentary Webinar. Presented by Kathy Knutson, Ph.D., EAS Independent Consultant. The food industry is built on a history of Good Manufacturing Practices, Hazard Analysis and Critical Control Points (HACCP), and the Food Safety Modernization Act (FSMA) with its...
FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
As has long been anticipated, FDA, on April 28, 2022, announced a proposed rule that would prohibit menthol as a characterizing flavor in cigarettes, and all characterizing flavors other than tobacco in cigars. Once finalized and implemented, FDA enforcement will address manufacturers,...
CTP’s Draft Guidance on Analytical Testing Methods Validation and Verification for Tobacco Products
What You Need to KnowPresented by Charlotte Peyton, EAS Independent Consultant. FDA’s December 2021 draft guidance on validation and verification testing methods used in analytical testing of tobacco products creates an opportunity and defined mechanism by which tobacco product manufacturers and...
Establishment Registration and Drug Listing Still a Challenge for Some
By Susan Crane, EAS Independent ConsultantIt’s now been 5 years since FDA updated the regulations for establishment registrations and drug listings. Despite numerous on-line reference materials and tutorials available, it appears that some companies still have difficulties understanding and...
Environmental Impact Assessments are Required by FDA, NEPA
By Charles Eirkson, EAS Independent ConsultantThe National Environmental Policy Act (NEPA, 1969), requires that potential environmental impact of actions, e.g., approvals of new drugs, biologics, food additives, be addressed by the U.S. Food and Drug Administration (FDA). In addition to FDA, NEPA...