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.
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 FDA’s new Draft Guidance includes steps companies may take to plan, prepare and initiate a voluntary...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
Nutrition Bar Manufacturing: A Quality Assurance Perspective
Natural Products Insider May 15, 2019 https://www.naturalproductsinsider.com/regulatory/nutrition-bar-manufacturing-quality-assurance-perspective Heather Fairman
FDA and Dietary Supplement Specifications
Tablets and Capsules Solid Dose Digest May 6, 2019 https://www.tabletscapsules.com/enews_tc/2019/issues/tcnews_05_06_19expert.html Tamika Cathey
Sayler Interviewed for Food Processing Magazine Article on Trump’s Effect on Food Industry
EAS Senior Director for Food Consulting Services, Allen Sayler, was interviewed for an article published in Food Processing Magazine on the regulatory state of the food industry under the Trump administration. Published during Scott Gottlieb’s tenure as FDA commissioner, Sayler discussed how...
Big Data, Real World Evidence and The Digital Revolution – Hang On!
By: John Brennan Executives from AbbVie, AstraZeneca, Bristol-Myers Squibb, Merck and Co., Johnson and Johnson, Pfizer and Sanofi were grilled on Capital Hill in February on topics ranging from drug pricing, reimbursement, rebates and patent extensions to executive compensation. Senators called...
510(k) Guidance and Substantial Equivalence Discussed in MedTech Intelligence
Independent Consultant, Jay Mansour, discussed the movement away from substantial equivalence in favor of performance testing for the 510(k) application process in a recent MedTech Intelligence. “Expanding on the Abbreviated 510(k) Program for demonstrating substantial equivalence for 510(k)...
Part-three of Food Safety Training for FSMA Series Published in Food Safety Magazine
Part-three of Dr. Mehrdad Tajkarimi’s series on designing proper employee training programs to ensure FSMA compliance was published in Food Safety Magazine. In this final section, Mehrdad discusses important training parameter matrices as well as development of effective training assessments.
Coleman on Opportunities for Pharma Streamlining of Product Innovations in ISPE iSpeak Blog
Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan Coleman, wrote a blog for the ISPE’s iSpeak on opportunities ahead for the pharma industry as the Agency works to streamline processes for improved innovations.
April 2019 Drug and Device Corner
It has come to EAS’s attention that there is significant confusion regarding the exemption of Class 1 Medical Device products to comply with the 21 CFR 801.20 requirement for the label of a medical device to bear a unique device identifier. Per 21 CFR 801.30 A class I device that FDA has by...
FDA to Begin Inspections for Intentional Adulteration in March 2020
FDA recently announced that verification of compliance with the Intentional Adulteration (IA) rule will begin in March 2020. Addressing hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health, the IA rule...
Stewart Discusses Dietary Supplement GMPs in Natural Products Insider
Senior Advisor for Dietary Supplements, Tim Stewart, discussed GMPs in Natural Products Insider. FDA has been asking for additional information beyond GMPs in recent inspections, inquiring on botanical forms and safety. Stewart discusses compliance challenges and best practices. In addition, Tim...
Insider Podcast on 25 Years of DSHEA Features Senior Director, Tara Lin Couch, Ph.D.
Tara Lin Couch was interviewed for a Natural Products Insider podcast on her reflections of 25 years of DSHEA. Recorded at SupplySide East, she discusses how the dietary supplement industry, pre-DSHEA, was the “wild, wild west” and that 21 CFR 111, Current Good Manufacturing Practices, completely...
FDA Proposing to Change the 510(k) Submission Process for Medical Devices
By George Yanulis Each month, EAS selects one question sent in by readers to be answered by one of our experts. This month’s question is answered by George Yanulis D.Eng., an expert in medical device safety and the 510(k) process. Question: Why is FDA proposing to change the 510(k) submission...
Final Rule on OTC Hand Sanitizers Issued
FDA issued a Final Rule, effective April 13, 2019, which aims to ensure the safety and effectiveness of OTC hand sanitizers, formally known as topical consumer antiseptic rub products. These products are intended for use without water and marketed under the FDA’s OTC Drug Review. Active...
Did You Know? EAS Offers Verification and Validation Services of Electronic Signatures Under 21 CFR Part 11
Increasing usage of electronic methods to capture and produce critical data, which are subject to regulatory scrutiny led to the effect of Title 21 CFR Part 11. This part of the Code of Federal Regulations establishes the United States Food and Drug Administration (FDA) regulations on electronic...
Levine Authors Article on Product Recalls in Natural Products Insider
Independent Consultant Ronald Levine authored an article on the very serious subject of product recalls published in the Natural Products Insider illustrated through a fictitious conversation between a hypothetical company’s CEO and their attorney as they plan for a recall response.
FDA Proposed Approach Aims to Improve Efficiencies to Advance Pharma Manufacturing
iSpeak Blog April 30, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/fda-proposed-approach-aims-improve-efficiencies-advance-pharma Neha Mookuparambil
Supply chain transparency: A practice of trust through legitimacy, from ‘farm to fork’
Natural Products Insider Apr 22, 2019 https://www.naturalproductsinsider.com/supply-chain/supply-chain-transparency-practice-trust-through-legitimacy-farm-fork Heather Fairman
Supply Chain Transparency: A Practice of Trust Through Legitimacy, From ‘Farm to Fork’
Natural Products Insider April 22, 2019 https://www.naturalproductsinsider.com/supply-chain/supply-chain-transparency-practice-trust-through-legitimacy-farm-fork Heather Fairman