Jun 1, 2019 | Drugs, EAS in Action, EASeNews
EAS regulatory intern Neha Mookuparambil authored a blog for ISPE iSpeak on FDA’s Proposed Approach to Improve Efficiencies for the Advancement of Pharma Manufacturing through Continuous Manufacturing. The FDA has been pushing for advanced manufacturing processes in...
Jun 1, 2019 | Drugs, EAS in Action, EASeNews
EAS independent consultant, Kaiser Aziz discussed FDA’s Quality Risk Management Approach to New Drug Applications in Drug Development and Delivery. Risk management is one of the most important tools in new drug applications to assess the risk level of a drug...
Jun 1, 2019 | EAS in Action, EASeNews
Join EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Director of Labeling and Cosmetics, Cathryn Sacra at the EAS booth #424 on June 3-5, 2019 at the IFT Annual Meeting in New Orleans. Discuss regulatory needs pertaining to foods and dietary...
May 1, 2019 | EAS in Action, EASeNews, Foods
EAS Senior Director for Food Consulting Services, Allen Sayler, was interviewed for an article published in Food Processing Magazine on the regulatory state of the food industry under the Trump administration. Published during Scott Gottlieb’s tenure as FDA...
May 1, 2019 | EAS in Action, EASeNews
Independent Consultant, Jay Mansour, discussed the movement away from substantial equivalence in favor of performance testing for the 510(k) application process in a recent MedTech Intelligence. “Expanding on the Abbreviated 510(k) Program for demonstrating...
May 1, 2019 | EAS in Action, EASeNews, Foods
Part-three of Dr. Mehrdad Tajkarimi’s series on designing proper employee training programs to ensure FSMA compliance was published in Food Safety Magazine. In this final section, Mehrdad discusses important training parameter matrices as well as development of...
