May 1, 2019 | Drugs, EAS in Action, EASeNews
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.
May 1, 2019 | Dietary Supplements, EAS in Action, EASeNews
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...
May 1, 2019 | EAS in Action, EASeNews
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...
May 1, 2019 | EAS in Action, EASeNews
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...
Apr 1, 2019 | EAS in Action, EASeNews
Steve Armstrong, EAS Independent Advisor for Food Law and Regulation, is co-author of an article published in the March 2019 Food Drug Law Institute Update Magazine covering FDA’s recent decision to delist six synthetic ingredients as required by the Delaney Clause, a...
Mar 1, 2019 | Dietary Supplements, EAS in Action, EASeNews
Since the passage of the Food Safety Modernization Act (FSMA) in 2011, dietary supplements are now subject to many aspects of the seven major regulations that were issued by FDA to support enforcement of FSMA. One of the most important of these regulations being 21...
