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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.

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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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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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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Retail Food Safety in a Post-Pandemic World

Retail Food Safety in a Post-Pandemic World

The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …

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Food Labeling Challenges in a Pandemic

Food Labeling Challenges in a Pandemic

Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent …

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Drug and Device Corner for May 2020

Drug and Device Corner for May 2020

FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent …

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