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.
July 2019 Drug and Device Corner
The FDA recently issued a warning letter to a company for inaccurate information in one of their drug listings. Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act and 21 CFR Part 207) outlines the requirements for registration and listing of drug products. EAS would like to...
ISPE iSpeak Blog on FDA’s ORA – A Historical Look and Evolving for the Future
Joel Martinez, former FDA ORA BIMO FDA Investigator, and EAS Independent Consultant shared a historical look at this important office and the evolution of training for FDA’s investigators of pharmaceutical products. Learn more here.
Determining the Risk-Base of High-Risk Foods
Each month EAS answers one question sent in by readers of EASeNews. This month’s question on the risk-base of high-risk foods is answered by EAS Independent Advisor for FSMA, Charles Breen. Question: How do you determine the Risk-Base of High-Risk Foods? Breen: With the passage of the Food Safety...
FDA Inspections Webinar with Recent Trends in Observations
EAS has posted our latest webinar to the On-Demand webinars page. Presented by Sophia Lily, Preparing for FDA Inspections, is free to view on-demand - along with numerous other webinars presented by our consultants on a variety of topics. EAS regulatory webinars provide timely and relevant content...
Preparing for FDA Inspections, a Look at Recent Observations and Trends
Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to …
FDA Office of Regulatory Affairs – A Historical Look and Evolving for the Future
ISPE iSpeak blog July 22, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/fda-office-regulatory-affairs-historical-look-and-evolving-future Joel Martinez
US Regulatory Considerations for Infant Formulas
Natural Products Insider July 22, 2019 https://www.naturalproductsinsider.com/regulatory/us-regulatory-considerations-infant-formulas Robert Burns
Risks to OLDs Discussed in Natural Products Insider
Independent Consultant Bruce Elsner discussed considerations of Own Label Distributors for the assurance of GMP compliance and certificates of analysis in Natural Products Insider. Dietary supplement companies that contract out some or all their operations often fail to consider how little...
Warehousing Compliance and FSMA Reviewed in Food Safety Strategies
The requirement to comply with FSMA is well understood for food manufacturers, and there are no exceptions for warehousing facilities. FDA inspections of facilities that receive, store and distribute human or animal food can occur at any time and firms must be prepared for such an inspection 24...
EAS to Offer Training on Expert Witness Preparations
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony...
How Does USDA Labeling Differ From FDA Food Labeling?
By Susan Glenn Each month EAS experts answer one question sent in by readers. This month’s answer regarding USDA labeling is provided by Susan Glenn. Susan is an expert in matters pertaining to USDA and FDA regulations of the food industry with a particular focus on labeling, product standards and...
Did you know? EAS Consulting Group Offers Preparatory Assessments Against VQIP Requirements for Firms
The Voluntary Qualified Import Program (VQIP) enables qualified importers of food and food products into the U.S. an expedited review and entry. However, meeting the stringent requirements of the VQIP program requires a thorough demonstration of documented safety of foreign suppliers of human and...
What are SDSs?
By Robert Kapp, Ph.D. Safety Data Sheets (SDSs) (formerly known as Material Data Sheets (MSDSs) contain basic information about a chemical or product needed to insure the safety and health of the user at all stages of its manufacture, storage, use, and disposal. Interestingly, SDSs have a long and...
June 2019 Drug and Device Corner
As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA...
Challenges with Implementing Cleaning Validation
By Miguel Montalvo Though published well over 25 years ago, FDA’s guidance surrounding cleaning validation continues to cause industry confusion. While everyone agrees that cleaning validation is critical, the application of incorrect or ineffective approaches whether by misunderstanding the...
EAS Offers Pre-Clinical Safety/Tox Study Services for GRAS and NDI Submissions.
EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the preparation and dossier...
What are the Steps to Reporting an Adverse Event to FDA?
By Robert Fish Each month EAS independent consultants answer one question sent in by readers of EASeNews. This month’s question on adverse events reporting for both OTCs and dietary supplements is answered by Independent Advisor for Quality and Compliance, Robert Fish. Mr. Fish spent 33 years with...
Final Guidance for Food Contact Notifications – Infant Formula and / or Human Milk
FDA’s Final Guidance for preparation of Food Contact Notifications for substances that come into contact with infant formula and human milk is intended to help industry understand FDA’s process for evaluating the safety of food contact substances. It incorporates the latest scientific...
Armstrong to Speak at CLE Intro to Food Law
EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, is an invited speaker for the fourth annual CLE Introduction to Food Law conference taking place June 6-7, 2019 at the UCLA Resnick Center for Food Law and Policy. Steve is a third time speaker at this Intro to Food Law...
EAS Exhibiting at Future Food Tech
EAS Senior Director for Food Consulting Services, Allen Sayler and Independent Consultant, Ron Levine, will represent EAS at Future Food Tech – NYC taking place June 18-19, 2019 in New York City. Stop by the EAS booth to learn more about our services for food innovators such as product development...
Fairman Authors Supply Chain Transparency and Quality Assurance Articles for Natural Products Insider
EAS Independent Consultant Heather Fairman authored two recent articles for Natural Products Insider. First, Supply Chain Transparency on the demand by consumers and regulators for supply chain transparency from farm to fork. Next, Quality Assurance for manufacturers of nutrition...
EAS Blogs on Proposed Efficiencies in Pharma Manufacturing
EAS regulatory intern Neha Mookuparambil authored a blog for ISPE iSpeak on FDA’s Proposed Approach to Improve Efficiencies for the Advancement of Pharma Manufacturing through Continuous Manufacturing. The FDA has been pushing for advanced manufacturing processes in the pharmaceutical industry....
FDA Strengthens Process of Initiating Voluntary Recalls
Voluntary recalls are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. FDA’s new Draft Guidance includes steps companies may take to plan, prepare and initiate a voluntary...
Final Guidance for Abbreviated Drug Application Submissions
FDA has issued Final Guidance related to drug marketing application submissions for human drugs and recommendations for considerations of whether to submit a 501(b)(2) New Drug Application, commonly referred to as an NDA, or a 505(j) Abbreviated New Drug Application, commonly referred to as an...
Aziz Authors Article on Risk Management in Drug Development and Delivery
EAS independent consultant, Kaiser Aziz discussed FDA’s Quality Risk Management Approach to New Drug Applications in Drug Development and Delivery. Risk management is one of the most important tools in new drug applications to assess the risk level of a drug product and promotes quality...
EAS to Exhibit at IFT Annual Meeting
Join EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Director of Labeling and Cosmetics, Cathryn Sacra at the EAS booth #424 on June 3-5, 2019 at the IFT Annual Meeting in New Orleans. Discuss regulatory needs pertaining to foods and dietary supplements and learn how EAS...
Veronica Ortiz de Montellano
Veronica Ortiz de Montellano Veronica Ortiz de Montellano is based in Mexico and offers assistance in foods, packaging and preservation. She is an expert in food design and process developments including structure, formulation and additives including Thermal Process controls and records for...
Common Pitfalls During Implementation of a Cleaning Validation Program
ISPE iSpeak blog May 30, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/common-pitfalls-during-implementation-cleaning-validation-program Miguel Montalvo
10 Key Questions an Own-Label Distributor Should Ask Itself
Natural Products Insider May 28, 2019 https://www.naturalproductsinsider.com/contract-manufacturing/10-key-questions-own-label-distributor-should-ask-itself Bruce Elsner
Warehouse Compliance to the Food Safety Modernization Act
Food Safety Strategies May 23, 2019 https://www.foodsafetystrategies.com/articles/809-warehouse-compliance-to-the-food-safety-modernization-act Jerry Heaps