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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.

Preparing for a PMTA Pre-Approval Inspection

Preparing for a PMTA Pre-Approval Inspection

Complimentary webinar presented by EAS Consulting Group and LabStat September 15, 2020 at 11:00am eastern Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services & Andrew Mooney, LabStat The Family Smoking Prevention and Tobacco Control Act referred...

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CIP Validation

CIP Validation

“Validation” is a term and concept that is widely used but is also widely misused and misunderstood. Validation of food safety control measures is currently a mandatory requirement in US, other countries and in internationally accepted regulations, but also in GFSI certification schemes, i.e. SQF, BRC, FSSC22000 and IFS. Several FDA and USDA regulations including FSMA Preventive Controls, LACF/AF…

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Drug and Device Corner July 2020

Drug and Device Corner July 2020

The FDA is remaining vigilant in their monitoring of OTC hand sanitizer products. Their highest concerns, from a manufacturing and marketing perspective, are hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. They are also taking action against...

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Understanding and Mitigating Risks of Emerging Pathogens

Understanding and Mitigating Risks of Emerging Pathogens

September 1, 2020 at 1pm eastern Presented by EAS Independent Consultants, Kathy Knutson, Ph.D. and Kathy Glass, Ph.D.  The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United...

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California Proposition 65 and the Food Industry

California Proposition 65 and the Food Industry

Key Issues and Practical GuidanceSeptember 24, 2020 at 1pm eastern Presented by EAS Independent Consultant Tom JonaitisProposition 65 is a statute that all companies selling products into California must comply with by providing warnings if their products contain certain chemicals that result in...

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Hygiene Improvement, Monitoring & Tracking

Hygiene Improvement, Monitoring & Tracking

While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data demonstrating a solid …

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GRAS for Cannabinoids

GRAS for Cannabinoids

FDA has not received and accepted any generally-recognized as safe for food-use (GRAS) notifications for purified cannabinoids (a.k.a. cannabinoid isolates) to date. Zero. Said another way, if the title of this article were a punny crossword puzzle clue, the only possible answer would be black squares…

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Drug and Device Corner June 2020

Drug and Device Corner June 2020

OTC Monograph reform is here. The FDA recently distributed an email to all drug establishments registered as OTC manufacturers in preparation for the Over-The-Counter Monograph User Fee Program (OMUFA). OTC Monograph Reform legislation passed by congress this spring has empowered the FDA to assess...

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Selecting and Submitting an ANDA Application

Selecting and Submitting an ANDA Application

The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until an ANDA …

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