Planning for Emergencies – Document, React and Manage all Aspects When the Worst Happens

Dear Readers,

Welcome to the October 2018 edition of the EAS-e-News, a free news publication for industries regulated by FDA. I’d like to invite you to view our latest video discussing EAS services in the infant formula industry. These short videos are a few minutes in length and designed to give you a better understanding of EAS capabilities and expertise of our many talented consultants. You may find all of our capability videos at the bottom of the page under the food tab of the EAS website.

We have a number of new webinars planned for the month of October and early November that we invite you to sign up for. From Preparing for Tobacco TPMPs, to Own Label Distributor Responsibilities and Pharma Data Integrity our complimentary webinars offer the latest regulatory information in a concise one-hour format with time for Q&A.

Independent Consultant, Priya Jambhekar will be speaking at FDLI’s Introduction to Biologics and Biosimilars Law and Regulation on the Regulation of Biological Marketing. This event is being held October 3-4, 2018 in Washington, D.C.. Dean Cirotta will be moderating a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference which is also being held in Washington, D.C. on October 25-26, 2018. Independent Advisor for OTC Drugs and Labeling, Susan Crane, will be presenting a session as part of the CHPA Academy’s OTC 101 course on OTC drug labeling regulations. This course is being offered in Wilmington, DE October 9-10, 2018.

Our Issue of the Month article is written by Independent Consultant Norma Skolnik and is on the legislation to reform the OTC Drug Monograph System called the OTC Drug Safety, Innovation, and Reform Act. EAS has a strong team of consultants who have in-depth knowledge of the OTC monograph process as well as the Rx to OTC switch. Our FSMA Perspective written by EAS Independent Advisor for FSMA, Charles Breen is on FDA’s new fee-based program Export Certifications for certain food products.

We hope you enjoy this issue of EAS-e-News and we hope that you’ll join us at one of our many webinars and presentations in the coming weeks. It is always a pleasure to meet those who also have a vested interest in ensuring the safety and compliance of FDA Regulated products. We welcome your questions and comments and please feel free to share this newsletter with your colleagues.

Sincerely,

Edward A. Steele

Posted in 2018, 2018 October, From the Desk of the Chairman.