Sep 10, 2020 | Dietary Supplements, Drugs, Medical Devices, Seminar, Tobacco
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
Aug 26, 2020 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…
May 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
On 1 April 2020, FDA Requests Removal of All Ranitidine Products from the Market immediately, for both prescription and OTC drugs. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications....
May 1, 2020 | EAS in Action, Medical Devices
EAS reminds all medical device firms that the compliance date by which devices must have a UDI is approaching. For more details on this requirement we invite you to read an EAS authored article in MedTech Intelligence. Timely compliance will ensure that your products...
Apr 8, 2020 | COVID-19, Medical Devices
Due to the ongoing COVID-19 pandemic, FDA has extended response due dates by 90 days for all Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and...
Apr 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
Please see the end of our monthly segment for COVID-19 specific information. The FDA issued a requirement for a stronger boxed warning about serious mental health side effects for the asthma and allergy drug montelukast. The FDA took this action after a review of...
