By Amy Scanlin, M.S.
As we began the third year of the current administration many wondered what priorities FDA would have in 2019. Without question, one of the most urgent became the challenge of identifying the cause of vaping illnesses and deaths that continue to confound the Centers for Tobacco Products. Thankfully as of this writing an initial window into a possible cause has been opened and certainly, this is an unfortunate reminder of the multitude of challenges that plague the safety of all our FDA regulated industries. With increasing globalization comes increasing demands on vigilance – placed on all of us – no matter our role, to ensure the products we produce, the methods by which they are sourced, manufactured, packaged, held and transported is done so with a laser focus on regulatory compliance. The adage of “if you see something, say something” is as crucial here as it is in any industry. We all have a role to support FDA’s commitment to safety.
The medical device industry is surely pleased with FDA’s focus on streamlining the incredible burden of bringing new products to market, particularly those that are predicated on earlier products or those that have similar safety and performance. Numerous guidance documents and draft guidance documents were released in 2019 which facilitate more innovation, strengthen security of connected devices, better define appropriate labeling and more. We look forward to the evolution of this industry and playing a supportive role as manufacturers streamline their own processes to work within FDA’s new mechanisms. To that end, EAS added a number of new regulatory consultants with medical device expertise this year who take clients through the process of clinical trials to commercialization to include operational readiness and audit preparation. We are very pleased with our medical device team and hope that if you are not already partnered with EAS as your regulatory consultant you will reach out to Bryan Coleman to learn more about our capabilities.
As you might expect, FDA released a number of food safety guidance documents this year. As the bulk of FSMA compliance dates are behind us with upcoming dates focusing primarily on smaller firms and farms, FDA is moving to an enforcement-based approach of safety. While the industry saw an increased number of recalls, in many cases those recalls were not preemptive, indicating a need to further strengthen our commitment to FSMA’s focus on prevention. Our Team FSMA, led by Senior Director for Food Consulting Services, Allen Sayler is tasked daily with food safety compliance requirements for both domestic and international clients. EAS consultants spoke at trade shows, conducted webinars and authored numerous articles on FSMA throughout the year. An easy way to access those articles, and many others is on the EAS in the News section of our website.
Of great importance to the pharmaceutical industry this year was FDA’s draft guidance which changes the submission organization that FDA will require going forward for Drug Master Files which house the CMCs for Active Pharmaceutical Ingredients (API) or a finished drug dosage form and maintain confidentiality of sensitive intellectual property, while allowing multiple pharmaceutical companies to collaborate in the development of new products. A timely EAS-hosted discussion of DMFs is scheduled December 13, 2019 when Priya Jambehkar, one of our esteemed consultants working with our pharmaceutical clients, will conduct a web-based training on the DMF process with Q&A time at the end.
While the dietary supplement industry did not receive new guidance documents this year, the Agency still had its hands full with enforcement of GMPs, as well as labeling and claims for products. Independent Advisor for Quality and Compliance Robert Fish conducted a very successful and very informative webinar on the subject in November, (found on the EAS On-Demand Webinars page) which discussed some of the more common Agency findings as well as information on strengthening manufacturing compliance. Did you know that some aspects of FSMA also apply to dietary supplements as they are a category of Food? If not, or you would like more information on compliance please join our webinar on the subject December 4, 2020.
As the year 2020 comes into focus, know that we at EAS are staying vigilant in our review and analysis of FDA requirements. Our consultants offer the proactive regulatory solutions in the best interests of EAS clients and we look forward to continuing to serve you and the industry in the coming year.