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...
Mar 30, 2020 | Cannabis, Cosmetics, COVID-19, Dietary Supplements, Drugs, Foods, Medical Devices, Tobacco, Veterinary
Dear EAS clients, Given the unprecedented challenges that we are all facing, I want you to know that our thoughts and prayers go out to you, your families, and employees. We are all learning how to work in new but effective ways while protecting our neighbors and...
Mar 20, 2020 | COVID-19, Dietary Supplements, Drugs, Foods, Medical Devices, Tobacco
FDA has announced an immediate partial stop work order to state contracted entities for activities such as compliance checks and vape shop inspections in light of the COVID-19 outbreak and in keeping with the White House Coronavirus Task Force and cross-government...
